Elevidys Kit
Product Images NDC 60923-540

Product Visual Gallery

This gallery contains 66 technical images submitted to the FDA as part of the official labeling for Elevidys (NDC 60923-540). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sarepta Therapeutics, 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 –carton Kit Label (Ele03 0013 01)

Elevidys (delandistrogene moxeparvovec-rokl) carton label for intravenous suspension for infusion. The label shows the concentration as 1.33 x 10^13 vector genomes per mL, instructions for single patient use, preservative-free status, storage conditions including -60°C for unopened vials, and manufacturer Sarepta Therapeutics, Inc. The label emphasizes no refreezing or shaking, and includes the Sarepta logo.*

FDA Label Image

Principal Display Panel -10 mL 10 Count Carton Label (Ele03 0013 02)

Label for ELEVIDYS KIT containing delandistrogene moxeparvovec-rokl, designed for intravenous use. The kit is intended for patients weighing 10.0 to 10.4 kg and includes 10 vials of 10 mL each along with 10 alcohol swabs. The label also shows a barcode, GTIN, serial number, lot number, and expiration date fields, with a space for the date of refrigeration. Labeled by Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 11 Count Carton Label (Ele03 0013 03)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label shows product name, barcode, GTIN, lot, and expiration details fields, plus kit contents listing 11 vials of 10 mL and 11 alcohol swabs, intended for patients weighing 10.5 to 11.4 kg. The labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 12 Count Carton Label (Ele03 0013 04)

Packaging label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label lists patient weight range (11.5 to 12.4 kg) and kit contents including 12 vials of 10 mL and 12 alcohol swabs. The label includes barcodes, placeholders for lot number, expiration date, and date of refrigeration. The product is labeled by Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 13 Count Carton Label (Ele03 0013 05)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, an intravenous human prescription drug by Sarepta Therapeutics, Inc. The label indicates kit contents include 13 vials of 10 mL each and 13 alcohol swabs, intended for patients weighing 12.5 to 13.4 kg. Also features barcode, GTIN, lot, and expiration placeholders.*

FDA Label Image

Principal Display Panel -10 mL 14 Count Carton Label (Ele03 0013 06)

Label for ELEVIDYS (delandistrogene moxeparvovec-rokl) kit for intravenous use by Sarepta Therapeutics, Inc. It includes patient weight range guidance, kit contents listing 14 vials of 10 mL each and 14 alcohol swabs, barcode, GTIN, serial number, lot number, and placeholder for expiration date and refrigeration date.*

FDA Label Image

Principal Display Panel -10 mL 15 Count Carton Label (Ele03 0013 07)

Label panel for ELEVIDYS kit featuring the proprietary name ELEVIDYS with the generic name delandistrogene moxeparvovec-rokl. The kit is intended for intravenous use and contains 15 vials of 10 mL each, plus 15 alcohol swabs. The label includes an NDC barcode, spaces for lot number, serial number, expiration date, and refrigeration date. The labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 16 Count Carton Label (Ele03 0013 08)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes patient weight range 15.5 to 16.4 kg, kit contents of 16 vials of 10 mL each and 16 alcohol swabs. It features a barcode, GTIN, serial number, lot number, and an empty field for date of refrigeration. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 17 Count Carton Label (Ele03 0013 09)

Label image for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes NDC 60923-508-17, barcode, GTIN, lot number, and expiration date fields. The kit is intended for patients weighing 16.5 to 17.4 kg and contains 17 vials of 10 mL each along with 17 alcohol swabs. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 18 Count Carton Label (Ele03 0013 10)

Packaging label for ELEVIDYS kit, containing delandistrogene moxeparvovec-rokl. The label indicates the kit contents include 18 vials of 10 mL each and 18 alcohol swabs. The product is labeled for intravenous use and shows barcode, GTIN, lot, and expiration placeholders. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 19 Count Carton Label (Ele03 0013 11)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes NDC 60923-510-19, barcodes, placeholders for lot number and expiration date, and kit contents specifying 19 vials of 10 mL each and 19 alcohol swabs, intended for patients weighing 18.5 to 19.4 kg. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 20 Count Carton Label (Ele03 0013 12)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, an intravenous human prescription drug by Sarepta Therapeutics, Inc. The label includes patient weight for dosing (19.5-20.4 kg), kit contents listing 20 vials of 10 mL each and 20 alcohol swabs, a barcode, and placeholders for lot and expiration dates.*

FDA Label Image

Principal Display Panel -10 mL 21 Count Carton Label (Ele03 0013 13)

ELEVIDYS delandistrogene moxeparvovec-rokl kit packaging label for intravenous use. The label shows the NDC code 60923-512-21, barcode, GTIN, lot number, and expiration date placeholders. It also lists kit contents as 21 vials of 10 mL and 21 alcohol swabs, with patient weight range 20.5-21.4 kg. The label indicates refrigeration details and includes a 2D matrix code marked FPO. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 22 Count Carton Label (Ele03 0013 14)

Label for ELEVIDYS kit, containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes text specifying patient weight range (21.5 - 22.4 kg), kit contents of 22 vials of 10 mL each and 22 alcohol swabs, and barcode information. There are placeholders for lot number, serial number, and expiration date details.*

FDA Label Image

Principal Display Panel -10 mL 23 Count Carton Label (Ele03 0013 15)

ELEVIDYS kit label showing the drug name delandistrogene moxeparvovec-rokl for intravenous use. The label includes patient weight guidelines (22.5-23.4 kg), kit contents of 23 vials (10 mL each) and 23 alcohol swabs, a barcode, and placeholders for lot number, serial number, expiration date, and refrigeration date. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 24 Count Carton Label (Ele03 0013 16)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl by Sarepta Therapeutics, Inc. It indicates the kit is for intravenous use and suitable for patient weight 23.5 to 24.4 kg. The kit contains 24 vials of 10 mL each and 24 alcohol swabs, with barcode, GTIN, serial number, lot, and expiration sections shown.*

FDA Label Image

Principal Display Panel -10 mL 25 Count Carton Label (Ele03 0013 17)

Label of ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label includes a barcode, GTIN number, and placeholders for serial number, lot number, and expiration date. It notes patient weight range 24.5 to 25.4 kg and kit contents of 25 vials of 10 mL each plus 25 alcohol swabs. The label is for intravenous use and produced by Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 26 Count Carton Label (Ele03 0013 18)

Label panel for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl by Sarepta Therapeutics, Inc. Displays NDC 60923-517-26, patient weight range 25.5 to 26.4 kg, and kit contents of 26 vials of 10 mL each with 26 alcohol swabs. Includes GTIN barcode and placeholders for lot number and expiration date.*

FDA Label Image

Principal Display Panel -10 mL 27 Count Carton Label (Ele03 0013 19)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, an intravenous human prescription drug by Sarepta Therapeutics, Inc. The label includes patient weight range (26.5-27.4 kg), kit contents of 27 vials of 10 mL each and 27 alcohol swabs, a barcode, and placeholders for lot number, expiration date, and refrigeration date.*

FDA Label Image

Principal Display Panel -10 mL 28 Count Carton Label (Ele03 0013 20)

Label for ELEVIDYS kit, containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes NDC 60923-519-28, patient weight range 27.5 to 28.4 kg, kit contents listing 28 vials of 10 mL each and 28 alcohol swabs, a barcode, and placeholders for serial number, lot number, and expiration date. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 29 Count Carton Label (Ele03 0013 21)

The label for ELEVIDYS kit featuring the active ingredient delandistrogene moxeparvovec-rokl. It includes barcode and GTIN information, patient weight range (28.5 - 29.4 kg), and kit contents of 29 vials (10 mL each) plus 29 alcohol swabs. There is a placeholder for the date of refrigeration and a matrix barcode with 'FPO' printed inside.*

FDA Label Image

Principal Display Panel -10 mL 30 Count Carton Label (Ele03 0013 22)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, an intravenous human prescription drug by Sarepta Therapeutics, Inc. The label includes NDC 60923-521-30 and details kit contents of 30 vials (10 mL each) with 30 alcohol swabs, intended for patients weighing 29.5 to 30.4 kg. Also shows barcode, placeholder expiration, lot, and serial numbers.*

FDA Label Image

Principal Display Panel -10 mL 31 Count Carton Label (Ele03 0013 23)

Label panel for ELEVIDYS kit containing the active ingredient delandistrogene moxeparvovec-rokl. The label shows the NDC 60923-522-31 with barcodes, placeholders for serial number, lot number, and expiration date. It specifies kit contents of 31 vials of 10 mL and 31 alcohol swabs, intended for intravenous administration, and includes patient weight range details. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 32 Count Carton Label (Ele03 0013 24)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label specifies kit contents as 32 vials of 10 mL and 32 alcohol swabs, for patients weighing 31.5 to 32.4 kg. Includes barcodes and placeholders for lot number, expiration date, and refrigeration date. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 33 Count Carton Label (Ele03 0013 25)

Label of ELEVIDYS (delandistrogene moxeparvovec-rokl) kit for intravenous use by Sarepta Therapeutics, Inc. The label shows patient weight range (32.5-33.4 kg), kit contents including 33 vials of 10 mL and 33 alcohol swabs, and includes barcodes, serial number, lot number, and expiration date placeholders.*

FDA Label Image

Principal Display Panel -10 mL 34 Count Carton Label (Ele03 0013 26)

Packaging label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl by Sarepta Therapeutics, Inc. The label specifies patient weight range (33.5 - 34.4 kg) and kit contents including 34 vials of 10 mL each and 34 alcohol swabs. The label features NDC barcode and GTIN code, with placeholders for lot number, serial number, expiration date, and date of refrigeration.*

FDA Label Image

Principal Display Panel -10 mL 35 Count Carton Label (Ele03 0013 27)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label includes the NDC number 60923-526-35, barcodes, and placeholders for lot number and expiration date. It specifies the kit contents as 35 vials of 10 mL each and 35 alcohol swabs, intended for patients weighing 34.5 to 35.4 kg. The labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 36 Count Carton Label (Ele03 0013 28)

Label for ELEVIDYS (delandistrogene moxeparvovec-rokl) kit for intravenous use by Sarepta Therapeutics, Inc. The label includes NDC 60923-527-36, kit contents indicating 36 vials of 10 mL each and 36 alcohol swabs, with placeholders for GTIN, serial number, lot number, and expiration date. The label also features barcodes and space for the date of refrigeration.*

FDA Label Image

Principal Display Panel -10 mL 37 Count Carton Label (Ele03 0013 29)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, an intravenous human prescription drug by Sarepta Therapeutics, Inc. The kit includes 37 vials of 10 mL and 37 alcohol swabs for patients weighing 36.5 to 37.4 kg. Label shows barcode, GTIN, lot, and expiry placeholders, with a refrigeration date box and a matrix barcode placeholder marked FPO.*

FDA Label Image

Principal Display Panel -10 mL 38 Count Carton Label (Ele03 0013 30)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, an intravenous human prescription drug by Sarepta Therapeutics, Inc. The kit includes 38 vials of 10 mL each and 38 alcohol swabs, for patients weighing 37.5 to 38.4 kg. The label shows a barcode, placeholders for lot number, expiration date, and refrigeration date.*

FDA Label Image

Principal Display Panel -10 mL 39 Count Carton Label (Ele03 0013 31)

Packaging label showing product name ELEVIDYS with active ingredient delandistrogene moxeparvovec-rokl, a human prescription drug in kit form for intravenous use. The label includes patient weight range (38.5-39.4 kg), kit contents (39 x 10 mL vials, 39 alcohol swabs), barcodes, and placeholders for lot number, serial number, and expiration date. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 40 Count Carton Label (Ele03 0013 32)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label specifies patient weight range (39.5 - 40.4 kg) and kit contents including 40 vials of 10 mL each and 40 alcohol swabs. It also shows a barcode, GTIN, serial number, lot number, and placeholder for expiration date and refrigeration date. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 41 Count Carton Label (Ele03 0013 33)

Label for ELEVIDYS (delandistrogene moxeparvovec-rokl) kit for intravenous use, showing barcode, placeholder for lot and expiration dates, and kit contents for a patient weight range 40.5-41.4 kg, including 41 vials of 10 mL each and 41 alcohol swabs. The label includes GTIN and manufacturer Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 42 Count Carton Label (Ele03 0013 34)

Label for ELEVIDYS (delandistrogene moxeparvovec-rokl) kit with NDC 60923-533-42. The label includes barcode, placeholder data for serial number, lot number, and expiration date, patient weight range (41.5 - 42.4 kg), and kit contents consisting of 42 vials of 10 mL each and 42 alcohol swabs. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 43 Count Carton Label (Ele03 0013 35)

Packaging label for ELEVIDYS kit, a human prescription drug containing delandistrogene moxeparvovec-rokl. The label includes the NDC 60923-534-43, a barcode, and spaces for lot number, serial number, and expiration date. Kit contents list 43 vials of 10 mL each and 43 alcohol swabs, with patient weight guidance of 42.5 to 43.4 kg. The labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 44 Count Carton Label (Ele03 0013 36)

ELEVIDYS kit label featuring the active ingredient delandistrogene moxeparvovec-rokl. The label includes the NDC 60923-535-44, a barcode, patient weight range (43.5-44.4 kg), and kit contents listing 44 x 10 mL vials and 44 alcohol swabs. There is space for refrigeration date, lot number, and expiration date information, along with a data matrix code marked FPO. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 45 Count Carton Label (Ele03 0013 37)

Label panel for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, an intravenous prescription drug by Sarepta Therapeutics. The label includes an NDC barcode (60923-536-45), placeholders for lot number and expiration date, patient weight range (44.5 - 45.4 kg), kit contents listing 45 vials of 10 mL each and 45 alcohol swabs, plus a date of refrigeration box.*

FDA Label Image

Principal Display Panel -10 mL 46 Count Carton Label (Ele03 0013 38)

Packaging label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label indicates the kit content includes 46 vials of 10 mL each with 46 alcohol swabs. It displays the NDC number 60923-537-46, a barcode, and spaces for lot number and expiration date. The label specifies patient weight range 45.5 to 46.4 kg and refrigeration date.*

FDA Label Image

Principal Display Panel -10 mL 47 Count Carton Label (Ele03 0013 39)

Label for ELEVYS kit containing delandistrogene moxeparvovec-rokl. The label details a patient weight range of 46.5 to 47.4 kg and kit contents including 47 vials of 10 mL each plus 47 alcohol swabs. It features barcodes and spaces for lot and expiration dates, distributed by Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 48 Count Carton Label (Ele03 0013 40)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label indicates kit contents include 48 vials of 10 mL each and 48 alcohol swabs. It displays a barcode, GTIN, serial number, lot number, and an area for the refrigeration date. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 49 Count Carton Label (Ele03 0013 41)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, an intravenous human prescription drug by Sarepta Therapeutics, Inc. The label includes barcode, serial number, lot number, and expiration date fields, with specific kit contents noted as 49 vials of 10 mL each and 49 alcohol swabs for patient weight 48.5 to 49.4 kg.*

FDA Label Image

Principal Display Panel -10 mL 50 Count Carton Label (Ele03 0013 42)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes NDC 60923-541-50, barcode, GTIN, serial number, lot, and expiration placeholders. Kit contents specify 50 vials of 10 mL each and 50 alcohol swabs for patients weighing 49.5 to 50.4 kg. Manufactured by Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel –carton Kit Label (Ele03 0013 43)

ELEVIDYS kit packaging label showing the proprietary name ELEVIDYS with the generic name delandistrogene moxeparvovec-rokl. It indicates a dosage strength of 1.33 x 10¹³ vector genomes/mL and is a suspension for infusion via intravenous use. The label includes storage instructions, single patient use note, preservative-free status, and manufacturer information for Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel –carton Kit Label (Ele03 0013 44)

Packaging label for ELEVIDYS (delandistrogene moxeparvovec-rokl) kit for intravenous use. The label displays the dosage strength as 1.33 x 10¹³ vector genomes/mL and indicates it is a suspension for infusion. It includes storage instructions, notes single patient use, and is marked as preservative-free. The labeler is Sarepta Therapeutics, Inc., Cambridge, MA.*

FDA Label Image

Principal Display Panel –vial Label (Ele03 0013 45)

ELEVIDYS (delandistrogene moxeparvovec-rokl) label showing concentration of 1.33 x 10^13 vector genomes/mL. It is a suspension for infusion, single-dose vial, 10 mL for intravenous use. Manufactured by Sarepta Therapeutics, Inc., Cambridge, MA, USA. Storage instructions and other handling details are also noted.*

FDA Label Image

Principal Display Panel -10 mL 51 Count Carton Label (Ele03 0013 46)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, an intravenous human prescription drug by Sarepta Therapeutics, Inc. The label includes the NDC 60923-542-51, GTIN barcode, placeholders for lot number and expiration date, and specifies kit contents for patient weight 50.5-51.4 kg as 51 ten-milliliter vials and 51 alcohol swabs.*

FDA Label Image

Principal Display Panel -10 mL 52 Count Carton Label (Ele03 0013 47)

Partial label of ELEVIDYS delandistrogene moxeparvovec-rokl kit for intravenous use by Sarepta Therapeutics, Inc. The label shows the NDC 60923-543-52 with barcodes, patient weight range (51.5 - 52.4 kg), and kit contents including 52 vials of 10 mL and 52 alcohol swabs. Placeholder spaces for lot number, serial number, and expiration date are also visible.*

FDA Label Image

Principal Display Panel -10 mL 53 Count Carton Label (Ele03 0013 48)

Packaging label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label shows the NDC code 60923-544-53, barcode, placeholders for lot number and expiration date, and indicates kit contents of 53 vials of 10 mL each and 53 alcohol swabs. Patient weight range is 52.5 to 53.4 kg. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 54 Count Carton Label (Ele03 0013 49)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label includes patient weight range 53.5 to 54.4 kg, kit contents of 54 vials of 10 mL each, and 54 alcohol swabs. It features a barcode, placeholders for GTIN, serial number, lot number, and expiration date, as well as a designation code '10146-01'. The label also has a box for recording the date of refrigeration. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 55 Count Carton Label (Ele03 0013 50)

Packaging label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label includes the product's NDC 60923-546-55, barcode, placeholders for serial number, lot number, and expiration date, and indicates kit contents and patient weight range. The label is from Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 56 Count Carton Label (Ele03 0013 51)

Packaging label for ELEVIDYS, containing the active ingredient delandistrogene moxeparvovec-rokl. The label indicates it is a kit for intravenous use, manufactured by Sarepta Therapeutics, Inc. It specifies patient weight range 55.5 to 56.4 kg and kit contents of 56 vials of 10 mL each along with 56 alcohol swabs. The label includes barcodes and placeholders for lot and expiration information.*

FDA Label Image

Principal Display Panel -10 mL 57 Count Carton Label (Ele03 0013 52)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, an intravenous human prescription drug by Sarepta Therapeutics, Inc. The label shows the NDC 60923-548-57, kit contents including 57 vials of 10 mL and 57 alcohol swabs. It includes a barcode, GTIN, lot, and expiration placeholders, and a refrigeration date box.*

FDA Label Image

Principal Display Panel -10 mL 58 Count Carton Label (Ele03 0013 53)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes patient weight guidance (57.5 - 58.4 kg), kit contents of 58 vials each 10 mL and 58 alcohol swabs, a barcode with GTIN, and placeholders for serial number, lot number, and expiration date. The label is from Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 59 Count Carton Label (Ele03 0013 54)

Label section for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. It specifies a patient weight range of 58.5 to 59.4 kg and kit contents including 59 ten-milliliter vials and 59 alcohol swabs. The label includes a barcode, GTIN, serial number, lot number, and an expiration date placeholder. The product is an intravenous human prescription drug by Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 60 Count Carton Label (Ele03 0013 55)

Label panel for ELEVIDYS delandistrogene moxeparvovec-rokl kit for intravenous use by Sarepta Therapeutics, Inc. The label lists patient weight range (59.5 - 60.4 kg) and kit contents including 60 vials of 10 mL and 60 alcohol swabs. It includes barcodes, GTIN, serial number, lot number, and expiration date placeholders.*

FDA Label Image

Principal Display Panel -10 mL 61 Count Carton Label (Ele03 0013 56)

Label panel for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. It specifies kit contents as 61 vials of 10 mL and 61 alcohol swabs, for patients weighing 60.5 to 61.4 kg. The label includes a barcode, placeholder text for lot number and expiration date, and refrigeration date box. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 62 Count Carton Label (Ele03 0013 57)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label includes packaging details such as patient weight range, kit contents of 62 vials (10 mL each) and 62 alcohol swabs, and barcodes. It also shows placeholders for lot number, expiration date, and refrigeration date. Labeler is Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 63 Count Carton Label (Ele03 0013 58)

Packaging label for ELEVIDYS, containing the nonproprietary name delandistrogene moxeparvovec-rokl. The kit includes 63 x 10 mL vials and 63 alcohol swabs suitable for patients weighing 62.5 to 63.4 kg. The label shows barcodes, placeholders for serial number, lot number, and expiration date, along with refrigeration instructions. Manufactured by Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 64 Count Carton Label (Ele03 0013 59)

Label for ELEVIDYS (delandistrogene moxeparvovec-rokl) kit, a human prescription drug for intravenous use by Sarepta Therapeutics, Inc. The label includes patient weight range (63.5-64.4 kg) and kit contents listing 64 vials of 10 mL and 64 alcohol swabs. Barcode and placeholder fields for serial number, lot number, and expiration date are also present.*

FDA Label Image

Principal Display Panel -10 mL 65 Count Carton Label (Ele03 0013 60)

Label for ELEVIDYS KIT containing delandistrogene moxeparvovec-rokl for intravenous use, manufactured by Sarepta Therapeutics, Inc. The label includes NDC 60923-556-65, with kit contents listed as 65 vials of 10 mL and 65 alcohol swabs. It also shows placeholders for lot number, expiration date, and refrigeration date, along with barcodes.*

FDA Label Image

Principal Display Panel -10 mL 66 Count Carton Label (Ele03 0013 61)

Label for ELEVIDYS (delandistrogene moxeparvovec-rokl) KIT for intravenous use by Sarepta Therapeutics, Inc. The label shows patient weight range and kit contents including 66 vials of 10 mL each and 66 alcohol swabs. It also includes a barcode, GTIN, serial number, lot number, and expiration date placeholder.*

FDA Label Image

Principal Display Panel -10 mL 67 Count Carton Label (Ele03 0013 62)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes the NDC 60923-558-67, barcode, kit contents specifying 67 vials of 10 mL and 67 alcohol swabs, and sections for patient weight and refrigeration date. The label also shows GTIN, lot number, and expiry date fields unfilled.*

FDA Label Image

Principal Display Panel -10 mL 68 Count Carton Label (Ele03 0013 63)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, an intravenous human prescription drug by Sarepta Therapeutics, Inc. The kit includes 68 vials of 10 mL each and 68 alcohol swabs, intended for patients weighing 67.5 to 68.4 kg. The label also shows a barcode, GTIN, lot, and expiration date placeholders.*

FDA Label Image

Principal Display Panel -10 mL 69 Count Carton Label (Ele03 0013 64)

Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes barcode, GTIN, serial number, lot, and expiration date placeholders. Kit contents specify 69 vials of 10 mL each and 69 alcohol swabs, suitable for patients weighing 68.5 to 69.4 kg. Labeled by Sarepta Therapeutics, Inc.*

FDA Label Image

Principal Display Panel -10 mL 70 Count Carton Label (Ele03 0013 65)

Label panel for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl by Sarepta Therapeutics. The label includes barcode, GTIN, SN, LOT, and expiration date placeholders. Kit contents are 70 vials of 10 mL each plus 70 alcohol swabs, intended for patients weighing 69.5 kg and above. Space is provided to record the date of refrigeration.*

FDA Label Image

Principal Display Panel – 10 mL Vial Label (Ele03 0013 66)

Packaging label for ELEVIDYS (delandistrogene moxeparvovec-rokl) 1.33 x 10¹³ vector genomes/mL suspension for infusion, intravenous use. The label includes directions to see enclosed prescribing information, notes it is Rx only, single-dose vial, and manufactured for Sarepta Therapeutics, Inc. Storage instructions specify unopened vials at or below -60°C and refrigerated conditions up to 14 days. Barcodes and NDC 60923-562-01 are visible on the label.*

* 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.