Fayuvi Kit
Product Images NDC 69794-317

Product Visual Gallery

This gallery contains 93 technical images submitted to the FDA as part of the official labeling for Fayuvi (NDC 69794-317). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ultragenyx Pharmaceutical Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label for FAYUVI kit containing rebisufligene etisparvovec-hopf. The kit includes 5 vials of 2 mL each, indicated for patients weighing 2.5 to 3.0 kg. The label shows the NDC 69794-301-05 and is from Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf suspension for intravenous infusion. The label shows a concentration of 1 x 10^13 vector genomes/mL. It instructs storage frozen at or below -60°C and to avoid shaking or refreezing. The product is for prescription use only, in single-dose vials, and contains no preservative. Manufactured by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

FAYUVI (rebisufligene etisparvovec-hopf) kit label showing the concentration of 1 x 10¹³ vector genomes/mL in a 2 mL suspension for intravenous infusion. The label indicates it is a single-dose vial, stored frozen at -60°C (-76°F) or below, with instructions to not shake or refreeze. Labeler is Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label for FAYUVI kit, a human prescription drug containing rebisufligene etisparvovec-hopf. The label specifies patient weight range of 3.1 to 4.0 kg and kit contents of six 2 mL vials. The barcode and NDC 69794-302-06 are visible, with Ultragenyx Pharmaceutical Inc. as the labeler.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf, a suspension for intravenous infusion with a strength of 1 x 10^13 vector genomes/mL. The label indicates single-dose vials, storage frozen at or below -60°C, no preservatives, and no U.S. standard potency. Manufactured by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit, a human prescription drug by Ultragenyx Pharmaceutical Inc. The label specifies a concentration of 1 x 10^13 vector genomes/mL in a 2 mL suspension for intravenous infusion. It indicates the product is a single-dose vial to be stored frozen at or below -60°C (-76°F), with instructions not to shake or refreeze.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label of FAYUVI kit containing rebisufligene etisparvovec-hopf, for patients weighing 4.1 to 5.0 kg. The kit includes 8 vials, each with 2 mL. The label displays the NDC 69794-303-08 and includes a barcode. The product is labeled by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf suspension for intravenous infusion. The label specifies a concentration of 1 x 10¹³ vector genomes/mL and that the product is for prescription use only in single-dose vials. Storage instructions indicate to keep frozen at -60°C (-76°F), avoid shaking, and protect from light. Manufactured by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc., containing a 2 mL suspension for intravenous infusion with a concentration of 1 x 10^13 vector genomes/mL. The label notes the product as a single-dose vial, to be stored frozen at or below -60°C (-76°F), and includes handling instructions to not shake or refreeze.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Packaging label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc. The label indicates a patient weight range of 5.1 to 6.0 kg and kit contents of nine 2 mL vials. The NDC number is 69794-346-09, accompanied by a barcode.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf at a concentration of 1 x 10¹³ vector genomes/mL. The label indicates it is a suspension for intravenous infusion, to be stored frozen at or below -60°C and protected from light. The label also notes no preservatives, no U.S. standard of potency, and that unused portions should be discarded. Manufactured by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI kit containing rebisufligene etisparvovec-hopf with concentration of 1 x 10^13 vector genomes/mL. The 2 mL suspension is for intravenous infusion. The label indicates a single-dose vial to be stored frozen at or below -60°C (-76°F), not to be shaken or refrozen. Provided by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label for FAYUVI kit containing rebisufligene etisparvovec-hopf from Ultragenyx Pharmaceutical Inc. The kit is for patients weighing 6.1 to 7.0 kg and includes 11 vials, each with 2 mL. The label also displays the NDC 69794-305-11 and a barcode.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf suspension for intravenous infusion. The label indicates a concentration of 1 x 10^13 vector genomes/mL and single-dose vials. Instructions include storage frozen at or below -60°C (-76°F), do not shake, protect from light, and do not refreeze. Manufactured by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc. It contains 2 mL suspension for intravenous infusion with a concentration of 1 x 10^13 vector genomes/mL. The single-dose vial must be stored frozen at -60°C (-76°F) or colder, not shaken, and not refrozen. Rx only.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label for FAYUVI kit with active ingredient rebisufligene etisparvovec-hopf. The label includes an NDC number (69794-306-12), specifies patient weight range of 7.1 to 8.0 kg, and states kit contents as 12 vials of 2 mL each. The labeler is Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton)

Carton label for FAYUVI kit containing rebisufligene etisparvovec-hopf suspension for intravenous infusion. The label highlights the strength as 1 x 10^13 vector genomes/mL and notes storage instructions including freezing at or below -60°C and protection from light. Manufactured by Ultragenyx Pharmaceutical Inc., the label also states it is Rx only and single-dose vials. The design includes blue, purple, and yellow stripes with the Ultragenyx logo.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

FAYUVI (rebisufligene etisparvovec-hopf) kit label showing concentration of 1 x 10^13 vector genomes/mL in a 2 mL suspension for intravenous infusion. The label indicates the product is a single-dose vial, stored frozen at or below -60°C (-76°F), with instructions not to shake or refreeze. Labeler is Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc. It includes patient weight indication of 8.1 to 9.0 kg and kit contents of 14 vials, each vial containing 2 mL. The label also features the NDC number 69794-307-14 and a barcode.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf. It is a suspension for intravenous infusion with a concentration of 1 x 10^13 vector genomes/mL in single-dose vials. The label includes storage instructions to keep frozen at or below -60°C and not to shake or refreeze the product. Manufactured by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

FAYUVI kit label showing rebisufligene etisparvovec-hopf dosage of 1 x 10^13 vector genomes per mL in a 2 mL suspension for intravenous infusion. The label indicates it is a single-dose vial, stored frozen at -60°C (-76°F), with instructions not to shake or refreeze. The labeler is Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label showing the product name FAYUVI with the active ingredient rebisufligene etisparvovec-hopf, designated for use in patients weighing 9.1 to 10.0 kg. The kit contains 15 vials of 2 mL each. The label includes the NDC number 69794-308-15 and is from Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf suspension for intravenous infusion. The label specifies a concentration of 1 x 10^13 vector genomes/mL, single-dose vials, and storage instructions to keep frozen at or below -60°C. The labeler is Ultragenyx Pharmaceutical Inc., Novato, CA.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) KIT by Ultragenyx Pharmaceutical Inc. Displays NDC 69794-300-01, concentration of 1 x 10^13 vector genomes/mL, 2 mL suspension for intravenous infusion. Instructions note single-dose vial, storage frozen at or below -60°C (-76°F), and warnings not to shake or refreeze the product.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc. The label lists NDC 69794-309-18 and specifies patient weight from 10.1 to 12.0 kg. Kit contents include 18 vials, each containing 2 mL. A barcode is present on the right side.*

FDA Label Image

Principal Display Panel (Kit Carton)

The packaging label for FAYUVI kit features the active ingredient rebisufligene etisparvovec-hopf with a concentration of 1 x 10^13 vector genomes/mL. It is labeled as a suspension for intravenous infusion, manufactured by Ultragenyx Pharmaceutical Inc. The label includes storage instructions to keep frozen below -60°C and caution notes such as no preservatives and discarding unused portions. The design includes colored stripes in yellow, purple, and blue along the edges and the Ultragenyx logo.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc. Displays dosage form as suspension for intravenous infusion, concentration of 1 x 10^13 vector genomes/mL, and volume of 2 mL. Indicates single-dose vial, storage instructions to keep frozen at -60°C (-76°F), and warnings not to shake or refreeze.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

FAYUVI kit label showing the proprietary name FAYUVI with the active ingredient rebisufligene etisparvovec-hopf. The label includes patient weight range 12.1 to 14.0 kg and kit contents of 21 vials, each 2 mL. The labeler is Ultragenyx Pharmaceutical Inc. A barcode is also present on the label.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf suspension for intravenous infusion. The label indicates 1 x 10^13 vector genomes/mL strength with storage instructions to keep frozen below -60°C (-76°F). The product is Rx only, supplied in single-dose vials, manufactured by Ultragenyx Pharmaceutical Inc. in Novato, CA. The label includes warnings against shaking and refreezing and notes no preservative is present.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

FAYUVI kit label showing rebisufligene etisparvovec-hopf at strength 1 x 10^13 vector genomes/mL in 2 mL suspension for intravenous infusion. The label indicates it is a single-dose vial, for Rx only, with storage instructions to keep frozen at or below -60°C (-76°F), and warnings against shaking or refreezing. Labeled by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label for FAYUVI kit containing rebisufligene etisparvovec-hopf, indicating patient weight range 14.1 to 16.0 kg and kit contents of 24 vials, each 2 mL. Includes numeric codes and a barcode. Labeler is Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit, containing rebisufligene etisparvovec-hopf at a concentration of 1 x 10^13 vector genomes/mL. It is a suspension for intravenous infusion, marked Rx only for single-dose vials, and is manufactured by Ultragenyx Pharmaceutical Inc. The label includes storage instructions, warnings against shaking and refreezing, and directs users to see prescribing information for dosage and administration.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI kit containing rebisufligene etisparvovec-hopf showing concentration of 1 x 10^13 vector genomes/mL in a 2 mL suspension for intravenous infusion. Label indicates single-dose vial, storage frozen at or below -60°C, and instructions not to shake or refreeze. The labeler is Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf. The label specifies patient weight range of 16.1 to 18.0 kg and kit contents include 27 vials of 2 mL each. The label shows the NDC number 69794-312-27 and the labeler Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf. The label indicates a concentration of 1 x 10^13 vector genomes/mL as a suspension for intravenous infusion. The label includes storage instructions to keep frozen at <-60°C, no shaking, and protection from light. It is marked Rx only for single-dose vials. Manufactured by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) injection kit by Ultragenyx Pharmaceutical Inc. It contains 2 mL suspension for intravenous infusion with a concentration of 1 x 10^13 vector genomes/mL. The single-dose vial is stored frozen at or below -60°C (-76°F) and should not be shaken or refrozen. Contains a clear overwrap area.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label for FAYUVI kit containing rebisufligene etisparvovec-hopf. The label indicates it is intended for patients weighing 18.1 to 20.0 kg and specifies kit contents of thirty 2 mL vials. The label includes the NDC 69794-313-30 and is from Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton)

FAYUVI kit packaging label featuring the drug name rebisufligene etisparvovec-hopf with a concentration of 1 x 10^13 vector genomes/mL. The label states it is a suspension for intravenous infusion, for single-dose vials, and prescription only. Storage instructions include keeping frozen below -60°C and protecting from light. The labeler is Ultragenyx Pharmaceutical Inc., located in Novato, CA, with U.S. License No. 2040.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

FAYUVI kit label with rebisufligene etisparvovec-hopf, showing a concentration of 1 x 10^13 vector genomes per mL. The label indicates a 2 mL suspension for intravenous infusion, stored frozen at or below -60°C, single-dose vial, Rx only, from Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label panel for FAYUVI kit containing rebisufligene etisparvovec-hopf. The label specifies a patient weight range of 20.1 to 22.0 kg and indicates the kit includes 33 vials, each with 2 mL. The label also displays the NDC 69794-314-33 and a barcode. The product is labeled by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf, a suspension for intravenous infusion at 1 x 10^13 vector genomes/mL. The label includes storage instructions, noting to store frozen at or below -60°C and do not shake or refreeze. The product is Rx only, supplied in single-dose vials, manufactured by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI kit containing rebisufligene etisparvovec-hopf indicated as a suspension for intravenous infusion. The label shows a concentration of 1 x 10^13 vector genomes/mL in a 2 mL single-dose vial. It includes storage instructions to keep frozen at or below -60°C (-76°F), warnings not to shake or refreeze, and is labeled Rx only. The labeler is Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf. The label indicates it is for patients weighing 22.1 to 24.0 kg and includes 36 vials, each 2 mL. The NDC number shown is 69794-315-36.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf at a strength of 1 x 10^13 vector genomes/mL. The suspension is for intravenous infusion. Label includes storage instructions to keep frozen below -60°C, warnings against shaking or refreezing, and notes it is Rx only with single-dose vials. Manufactured by Ultragenyx Pharmaceutical Inc., Novato, CA, with the company logo present.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI kit containing rebisufligene etisparvovec-hopf, with a concentration of 1 x 10^13 vector genomes per mL in a 2 mL suspension for intravenous infusion. The label indicates the product is a single-dose vial, stored frozen at or below -60°C, should not be shaken or refrozen, and is Rx only. Labeler is Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

NDC 69794-316-39 label for FAYUVI, containing rebisufligene etisparvovec-hopf. The label specifies patient weight range of 24.1 to 26.0 kg and kit contents of 39 vials, each 2 mL. Barcode and numeric product identifiers are also displayed.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf at 1 x 10¹³ vector genomes/mL. The label states it is a suspension for intravenous infusion, for single-dose vials, labeled Rx only. Storage instructions and manufacturer details for Ultragenyx Pharmaceutical Inc. are included. The design features blue, purple, and yellow accents with the Ultragenyx logo.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

The label for FAYUVI (rebisufligene etisparvovec-hopf) shows a single-dose vial kit with a concentration of 1 x 10^13 vector genomes/mL in 2 mL suspension for intravenous infusion. Storage instructions indicate it must be kept frozen at or below -60°C (-76°F), must not be shaken or refrozen. The product is labeled by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label panel for FAYUVI (rebisufligene etisparvovec-hopf) KIT from Ultragenyx Pharmaceutical Inc. It specifies patient weight range of 26.1 to 28.0 kg and indicates kit contents include 42 vials of 2 mL each. A barcode and NDC number 69794-317-42 are also visible.*

FDA Label Image

Principal Display Panel (Kit Carton)

The unfolded carton label for FAYUVI, a kit containing rebisufligene etisparvovec-hopf suspension for intravenous infusion at a concentration of 1 x 10^13 vector genomes/mL. The label includes storage instructions to keep frozen at -60°C (-76°F), handling warnings, and manufacturer details for Ultragenyx Pharmaceutical Inc. The label notes Rx only and single-dose vials.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc. It indicates a 2 mL suspension for intravenous infusion with a concentration of 1 x 10^13 vector genomes/mL. The label notes the product is a single-dose vial that requires freezing at -60°C (-76°F), with instructions not to shake or refreeze.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label for FAYUVI kit containing rebisufligene etisparvovec-hopf, a human prescription drug by Ultragenyx Pharmaceutical Inc. The kit is intended for patients weighing 28.1 to 30.0 kg and includes 45 vials, each with a 2 mL volume. The label also displays the NDC 69794-318-45 and a barcode.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf suspension for intravenous infusion at a strength of 1 x 10^13 vector genomes per mL. Label indicates it is for single-dose vials, prescription use only, and includes storage instructions to keep frozen at or below -60°C. Manufactured by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc. It shows a suspension for intravenous infusion with a concentration of 1 x 10¹³ vector genomes/mL in a 2 mL single-dose vial. Storage instructions include keeping frozen at or below -60°C (-76°F), with warnings not to shake or refreeze.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Packaging label of FAYUVI kit containing rebisufligene etisparvovec-hopf. The label indicates the kit is intended for patients weighing between 30.1 to 32.0 kg and includes 48 vials, each with a 2 mL volume. The label also features the NDC 69794-319-48 and a barcode. The labeler is Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf, suspension for intravenous infusion with strength of 1 x 10¹³ vector genomes/mL. Label includes storage instructions, manufacturer Ultragenyx Pharmaceutical Inc., and notes that the product is Rx only and provided in single-dose vials. The design features colored stripes in yellow, purple, and blue on the edges and the Ultragenyx logo.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

FAYUVI rebisufligene etisparvovec-hopf 2 mL suspension for intravenous infusion kit label. The label shows a concentration of 1 x 10^13 vector genomes/mL, storage instructions to keep frozen at or below -60°C (-76°F), and warnings including single-dose vial, Do Not Shake, and Do Not Refreeze. The labeler is Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf. The label specifies patient weight of 32.1 to 34.0 kg and kit contents of 51 vials, each 2 mL. It includes the NDC number 69794-320-51 and a barcode. The labeler is Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf suspension for intravenous infusion. The label specifies a concentration of 1 x 10^13 vector genomes/mL, with instructions to store frozen at or below -60°C and not to shake or refreeze. The labeler is Ultragenyx Pharmaceutical Inc. The product is Rx only and supplied in single-dose vials.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc. Shows strength as 1 x 10¹³ vector genomes/mL in a 2 mL suspension for intravenous infusion. The label indicates a single-dose vial, storage frozen at or below -60°C (-76°F), with instructions not to shake or refreeze.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label of FAYUVI kit containing rebisufligene etisparvovec-hopf, a human prescription drug by Ultragenyx Pharmaceutical Inc. The kit is for patients weighing 34.1 to 36.0 kg and includes 54 vials of 2 mL each. The label includes NDC 69794-321-54 and a barcode.*

FDA Label Image

Principal Display Panel (Kit Carton)

Box packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf, a suspension for intravenous infusion with a strength of 1 x 10^13 vector genomes/mL. The label includes storage instructions, prescribing information note, and manufacturer details indicating Ultragenyx Pharmaceutical Inc. It states the product is Rx only and single-dose vials. The label design features blue, purple, and yellow color bands.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

FAYUVI (rebisufligene etisparvovec-hopf) kit label from Ultragenyx Pharmaceutical Inc. showing a suspension for intravenous infusion with a concentration of 1 x 10¹³ vector genomes/mL in a 2 mL single-dose vial. The label indicates Rx only, storage frozen at or below -60°C (-76°F), and instructions not to shake or refreeze the vial.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf. The label indicates the kit is for patients weighing 36.1 to 38.0 kg and includes 57 vials of 2 mL each. The labeler is Ultragenyx Pharmaceutical Inc. The label shows the NDC 69794-322-57 and includes a barcode.*

FDA Label Image

Principal Display Panel (Kit Carton)

Label for FAYUVI kit containing rebisufligene etisparvovec-hopf, with a strength of 1 x 10^13 vector genomes/mL. It is a suspension for intravenous infusion labeled for single-dose vials. The label includes storage instructions to keep frozen at or below -60°C (-76°F) and not to shake or refreeze. Manufactured by Ultragenyx Pharmaceutical Inc., the packaging features colored stripes in yellow, purple, and blue on top and sides, with prescribing information reference and a barcode on the main label panel.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc. It contains suspension for intravenous infusion with a concentration of 1 x 10^13 vector genomes/mL in a 2 mL single-dose vial. The label warns to store frozen at or below -60°C (-76°F), not to shake or refreeze the vial, and indicates it is Rx only.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc. Includes NDC 69794-323-60 and indicates patient weight range 38.1 to 40.0 kg. Kit contains 60 vials, each 2 mL in volume. Barcode and additional numeric codes are present.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI, containing rebisufligene etisparvovec-hopf suspension for intravenous infusion at a concentration of 1 x 10^13 vector genomes/mL. The label includes usage instructions, storage conditions, and manufacturer details from Ultragenyx Pharmaceutical Inc. It specifies single-dose vials, Rx only, with no preservative and discarding unused portions.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc. Shows concentration as 1 x 10^13 vector genomes/mL, volume 2 mL. Indicates suspension for intravenous infusion, single-dose vial, store frozen at -60°C (-76°F), do not shake or refreeze.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Packaging label for FAYUVI kit, containing rebisufligene etisparvovec-hopf. The label specifies patient weight range of 40.1 to 42.0 kg and kit contents of 63 vials, each 2 mL. Also includes NDC 69794-324-63 and a barcode. Labeler is Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc. The label indicates a suspension for intravenous infusion with a concentration of 1 x 10^13 vector genomes/mL. It includes storage instructions, dosage form, and regulatory information. The design features horizontal colored stripes (yellow, purple, blue) and clear text with details on single-dose vials and prescription use only.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI kit containing rebisufligene etisparvovec-hopf, showing 1 x 10^13 vector genomes/mL in a 2 mL suspension for intravenous infusion. The label includes storage instructions to keep frozen at or below -60°C, and warnings not to shake or refreeze. Labeler is Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label of FAYUVI kit containing rebisufligene etisparvovec-hopf, a human prescription drug by Ultragenyx Pharmaceutical Inc. The kit is designated for patients weighing 42.1 to 46.0 kilograms. Kit contents include 69 vials, each with a volume of 2 mL. The label also displays the NDC code 69794-325-69 and a barcode.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf suspension for intravenous infusion. The label indicates a concentration of 1 x 10^13 vector genomes/mL. It states the product is for single-dose vials, requires storage frozen at -60°C (-76°F), and should not be shaken or refrozen. The labeler is Ultragenyx Pharmaceutical Inc., Novato, CA.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

FAYUVI (rebisufligene etisparvovec-hopf) kit label showing dosage strength of 1 x 10^13 vector genomes per mL in a 2 mL suspension for intravenous infusion. The label indicates single-dose vial usage with storage instructions to keep frozen at or below -60°C (-76°F), and warnings not to shake or refreeze. Labeler is Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc., including NDC 69794-326-75. Specifies patient weight range 46.1 to 50.0 kg and kit contents of 75 vials, each containing 2 mL. Also includes a barcode and product code information.*

FDA Label Image

Principal Display Panel (Kit Carton)

The image shows the unfolded packaging label for FAYUVI, a kit dosage form containing rebisufligene etisparvovec-hopf. The label includes product strength as 1 x 10^13 vector genomes/mL and identifies it as a suspension for intravenous infusion. The label states storage instructions, manufacturer Ultragenyx Pharmaceutical Inc., and indicates the product is Rx only in single-dose vials. The design features colored stripes in yellow, purple, and blue, and the Ultragenyx logo at the bottom.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc. The label shows the concentration as 1 x 10^13 vector genomes per mL with a 2 mL suspension for intravenous infusion. It is a single-dose vial that should be stored frozen at or below -60°C (-76°F), with instructions not to shake or refreeze the product.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label for FAYUVI rebisufligene etisparvovec-hopf kit by Ultragenyx Pharmaceutical Inc. The label includes patient weight range (50.1 to 54.0 kg) and kit contents of 81 vials, each 2 mL. It displays the NDC number 69794-327-81 and a barcode.*

FDA Label Image

Principal Display Panel (Kit Carton)

FAYUVI kit label for rebisufligene etisparvovec-hopf, 1 x 10^13 vector genomes/mL, suspension for intravenous infusion. The label includes storage instructions to keep frozen at or below -60°C and warnings not to shake or refreeze. It indicates single-dose vials, no preservative, no U.S. standard of potency, and discard unused portion. Manufactured by Ultragenyx Pharmaceutical Inc., Novato, CA. The label design features blue, purple, and yellow stripes and includes prescribing instructions reference.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) 1 x 10^13 vector genomes/mL suspension for intravenous infusion, 2 mL single-dose vial. The label includes storage instructions to keep frozen at -60°C (-76°F), advises not to shake or refreeze, and states Rx only. Produced by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label for FAYUVI kit containing rebisufligene etisparvovec-hopf, a human prescription drug by Ultragenyx Pharmaceutical Inc. The kit is intended for patients weighing between 54.1 to 58.0 kg and includes 87 vials, each vial containing 2 mL.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI, containing rebisufligene etisparvovec-hopf, a suspension for intravenous infusion. The label indicates a concentration of 1 x 10^13 vector genomes/mL and specifies storage instructions to keep frozen at or below -60°C (-76°F) without shaking or refreezing. The label also notes that the product is for single-dose vials, contains no preservative, and should discard unused portions. Manufactured by Ultragenyx Pharmaceutical Inc., Novato, CA.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI kit containing rebisufligene etisparvovec-hopf, a human prescription drug by Ultragenyx Pharmaceutical Inc. The label indicates a single-dose vial with a 2 mL suspension for intravenous infusion at a concentration of 1 x 10^13 vector genomes/mL. Storage instructions specify frozen storage at or below -60°C (-76°F) with warnings not to shake or refreeze.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label for FAYUVI kit containing rebisufligene etisparvovec-hopf, indicating patient weight range between 58.1 to 62.0 kg. The kit contents include 93 vials, each 2 mL. Product is labeled by Ultragenyx Pharmaceutical Inc. The label includes an NDC number 69794-329-93 and a barcode.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf suspension for intravenous infusion. The label indicates a concentration of 1 x 10^13 vector genomes/mL, includes storage instructions to keep frozen at -60°C (-76°F), and notes it is a single-dose vial with no preservative. Manufactured by Ultragenyx Pharmaceutical Inc.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc. It indicates a suspension for intravenous infusion with a concentration of 1 x 10^13 vector genomes per mL and a volume of 2 mL. The label instructs storage frozen at or below -60°C (-76°F), single-dose vial, do not shake or refreeze, and states Rx only.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Label for FAYUVI kit containing rebisufligene etisparvovec-hopf, a human prescription drug by Ultragenyx Pharmaceutical Inc. The label includes the NDC 69794-330-99 and specifies patient weight range from 62.1 to 66.0 kg. Kit contents include 99 vials of 2 mL each. A barcode is also visible on the label.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf. The label indicates a suspension for intravenous infusion with a concentration of 1 x 10^13 vector genomes/mL. It includes manufacturer details for Ultragenyx Pharmaceutical Inc., storage instructions, and usage notes. The design features colorful stripes in yellow, purple, and blue.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI, rebisufligene etisparvovec-hopf, a human prescription drug kit by Ultragenyx Pharmaceutical Inc. It includes concentration information of 1 x 10^13 vector genomes/mL in a 2 mL suspension for intravenous infusion. The label also states storage instructions: single-dose vial, store frozen at or below -60°C (-76°F), do not shake or refreeze.*

FDA Label Image

Principal Display Panel (Kit Carton Label)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf by Ultragenyx Pharmaceutical Inc. The label specifies patient weight range 66.1 to 70.0 kg and kit contents of 105 vials, each 2 mL. Includes NDC 69794-331-05 and a barcode.*

FDA Label Image

Principal Display Panel (Kit Carton)

Packaging label for FAYUVI kit containing rebisufligene etisparvovec-hopf suspension for intravenous infusion. The label lists strength as 1 x 10^13 vector genomes/mL. It includes storage instructions to keep frozen at -60°C (-76°F) and warnings against shaking or refreezing. Manufactured by Ultragenyx Pharmaceutical Inc., Novato, CA, with U.S. License No. 2040. The label also notes the product is Rx only, single-dose vials, no preservative, and no U.S. standard for potency.*

FDA Label Image

Principal Display Panel (2 mL Vial Label)

Label for FAYUVI (rebisufligene etisparvovec-hopf) kit by Ultragenyx Pharmaceutical Inc. It is a suspension for intravenous infusion with a concentration of 1 x 10¹³ vector genomes/mL in a 2 mL single-dose vial. The label includes storage instructions to keep frozen at -60°C (-76°F), do not shake or refreeze, and is marked Rx only.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.