Elevidys Kit
Product Images NDC 60923-501

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 65 technical images submitted to the FDA as part of the official labeling for Elevidys (NDC 60923-501). 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.

Product Images & Figures Index

FDA Label Image

Principal Display Panel –carton Kit Label (Ele03 0003 01)

Principal Display Panel –carton Kit Label (Ele03 0003 01)
ELEVIDYS (delandistrogene moxeparvovec-rokl) kit label for intravenous suspension for infusion. The label shows a concentration of 1.33 x 10^13 vector genomes per mL. It includes storage instructions, manufacturer Sarepta Therapeutics, Inc., and usage notes such as single patient use and preservative-free status.*
FDA Label Image

Principal Display Panel -10 mL 10 Count Carton Label (Ele03 0003 02)

Principal Display Panel -10 mL 10 Count Carton Label (Ele03 0003 02)
Label for ELEVIDYS (delandistrogene moxeparvovec-rokl) kit for intravenous use by Sarepta Therapeutics, Inc. The label includes the NDC number 60923-501-10 and details that the kit contents are for patient weight 10.0 to 10.4 kg, including 10 vials of 10 mL each and 10 alcohol swabs. It also shows barcode, GTIN, serial number, lot number, and expiration date fields.*
FDA Label Image

Principal Display Panel -10 mL 11 Count Carton Label (Ele03 0003 03)

Principal Display Panel -10 mL 11 Count Carton Label (Ele03 0003 03)
Packaging label for ELEVIDYS, containing delandistrogene moxeparvovec-rokl. The label shows kit contents including 11 vials of 10 mL each and 11 alcohol swabs. It includes barcodes, GTIN, serial number, lot number, and expiration date placeholder. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 12 Count Carton Label (Ele03 0003 04)

Principal Display Panel -10 mL 12 Count Carton Label (Ele03 0003 04)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The kit is intended for intravenous use and includes 12 vials of 10 mL each, plus 12 alcohol swabs. The label displays the NDC number 60923-503-12, barcodes, and placeholders for lot number, serial number, expiration date, and date of refrigeration. The labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 13 Count Carton Label (Ele03 0003 05)

Principal Display Panel -10 mL 13 Count Carton Label (Ele03 0003 05)
Partial label of ELEVIDYS (delandistrogene moxeparvovec-rokl) kit showing NDC 60923-504-13. Includes barcode, kit contents for patient weight 12.5-13.4 kg consisting of 13 vials (10 mL each) and 13 alcohol swabs, a placeholder for date of refrigeration, and serial, lot, and expiration date fields.*
FDA Label Image

Principal Display Panel -10 mL 14 Count Carton Label (Ele03 0003 06)

Principal Display Panel -10 mL 14 Count Carton Label (Ele03 0003 06)
Label of ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes the NDC number 60923-505-14, a barcode, lot and expiration placeholders, and kit content information for patients weighing 13.5 to 14.4 kg, listing 14 vials of 10 mL each and 14 alcohol swabs. The label also features a QR code marked 'FPO'.*
FDA Label Image

Principal Display Panel -10 mL 15 Count Carton Label (Ele03 0003 07)

Principal Display Panel -10 mL 15 Count Carton Label (Ele03 0003 07)
ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes barcode and GTIN information, patient weight guidelines (14.5-15.4 kg), and kit contents of 15 vials of 10 mL each and 15 alcohol swabs. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 16 Count Carton Label (Ele03 0003 08)

Principal Display Panel -10 mL 16 Count Carton Label (Ele03 0003 08)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label includes the NDC 60923-507-16, a barcode, and human prescription drug designation by Sarepta Therapeutics, Inc. It specifies patient weight between 15.5 to 16.4 kg and kit contents of sixteen 10 mL vials with sixteen alcohol swabs. There is space for date of refrigeration, along with GTIN, serial number, lot number, and expiration date placeholders.*
FDA Label Image

Principal Display Panel -10 mL 17 Count Carton Label (Ele03 0003 09)

Principal Display Panel -10 mL 17 Count Carton Label (Ele03 0003 09)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label includes the NDC 60923-508-17, barcodes, and sections for patient weight range, kit contents of 17 vials of 10 mL each, and 17 alcohol swabs. It also has fields for date of refrigeration, serial number, lot number, and expiration date. The label shows the labeler as Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 18 Count Carton Label (Ele03 0003 10)

Principal Display Panel -10 mL 18 Count Carton Label (Ele03 0003 10)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label includes NDC 60923-509-18, patient weight range 17.5-18.4 kg, and kit contents of eighteen 10 mL vials plus eighteen alcohol swabs. Also visible are barcodes, placeholders for lot number, serial number, expiration date, and refrigeration date, and a QR code marked FPO.*
FDA Label Image

Principal Display Panel -10 mL 19 Count Carton Label (Ele03 0003 11)

Principal Display Panel -10 mL 19 Count Carton Label (Ele03 0003 11)
Packaging label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label shows barcode, GTIN, serial number, lot number, and expiration date placeholder. It notes kit contents with 19 vials of 10 mL each and 19 alcohol swabs. Label also indicates patient weight range for dosing and has refrigeration date box. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 20 Count Carton Label (Ele03 0003 12)

Principal Display Panel -10 mL 20 Count Carton Label (Ele03 0003 12)
Label for ELEVIDYS (delandistrogene moxeparvovec-rokl) intravenous kit by Sarepta Therapeutics, Inc. The label includes patient weight range 19.5-20.4 kg and kit contents: 20 x 10 mL vials and 20 alcohol swabs. It also shows a barcode, GTIN, serial number, lot number, and expiration date placeholders.*
FDA Label Image

Principal Display Panel -10 mL 21 Count Carton Label (Ele03 0003 13)

Principal Display Panel -10 mL 21 Count Carton Label (Ele03 0003 13)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, an intravenous human prescription drug by Sarepta Therapeutics, Inc. The label includes product and dosage details with barcode, GTIN, serial number, lot number, and an expiration date placeholder. Kit contents mention 21 vials of 10 mL each and 21 alcohol swabs intended for patients weighing 20.5 to 21.4 kg.*
FDA Label Image

Principal Display Panel -10 mL 22 Count Carton Label (Ele03 0003 14)

Principal Display Panel -10 mL 22 Count Carton Label (Ele03 0003 14)
The image shows a label for ELEVIDYS (delandistrogene moxeparvovec-rokl) KIT for intravenous use. It includes a barcode, GTIN code, and placeholders for serial number, lot number, and expiration date. The label also notes kit contents of 22 vials of 10 mL each and 22 alcohol swabs, with patient weight guidance of 21.5 to 22.4 kg. The product is labeled by Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 23 Count Carton Label (Ele03 0003 15)

Principal Display Panel -10 mL 23 Count Carton Label (Ele03 0003 15)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, an intravenous human prescription drug by Sarepta Therapeutics, Inc. It specifies patient weight range (22.5-23.4 kg), kit contents including twenty-three 10 mL vials and twenty-three alcohol swabs, barcode, and placeholders for GTIN, serial number, lot number, and expiration date.*
FDA Label Image

Principal Display Panel -10 mL 24 Count Carton Label (Ele03 0003 16)

Principal Display Panel -10 mL 24 Count Carton Label (Ele03 0003 16)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, an intravenous human prescription drug by Sarepta Therapeutics, Inc. The label shows the NDC 60923-515-24, kit contents including 24 vials of 10 mL each and 24 alcohol swabs, intended for patients weighing 23.5 to 24.4 kg. It also features a barcode, spaces for lot number, expiration date, and date of refrigeration.*
FDA Label Image

Principal Display Panel -10 mL 25 Count Carton Label (Ele03 0003 17)

Principal Display Panel -10 mL 25 Count Carton Label (Ele03 0003 17)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes barcode, GTIN, lot number, expiration date placeholders, and kit contents listing 25 vials of 10 mL and 25 alcohol swabs. Patient weight range 24.5-25.4 kg noted. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 26 Count Carton Label (Ele03 0003 18)

Principal Display Panel -10 mL 26 Count Carton Label (Ele03 0003 18)
Packaging label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label includes the NDC 60923-517-26, barcode, and information about kit contents for patient weight 25.5 to 26.4 kg, including 26 x 10 mL vials and 26 alcohol swabs. There is space for the date of refrigeration and various serial/lot/expiration placeholders.*
FDA Label Image

Principal Display Panel -10 mL 27 Count Carton Label (Ele03 0003 19)

Principal Display Panel -10 mL 27 Count Carton Label (Ele03 0003 19)
Packaging label for ELEVIDYS, delandistrogene moxeparvovec-rokl, showing the product as a kit for intravenous use. The label includes a barcode, placeholders for GTIN, serial number, lot number, and expiration date, along with kit contents specifying 27 x 10 mL vials and 27 alcohol swabs, and patient weight range 26.5 to 27.4 kg. The labeler name Sarepta Therapeutics, Inc. is indicated in product data but not visible in the image.*
FDA Label Image

Principal Display Panel -10 mL 28 Count Carton Label (Ele03 0003 20)

Principal Display Panel -10 mL 28 Count Carton Label (Ele03 0003 20)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label indicates the patient weight range of 27.5 to 28.4 kg, with kit contents including 28 vials of 10 mL each and 28 alcohol swabs. Also shows barcode, GTIN, serial number, lot number, and expiration date fields (blank). Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 29 Count Carton Label (Ele03 0003 21)

Principal Display Panel -10 mL 29 Count Carton Label (Ele03 0003 21)
Label for ELEVIDYS delandistrogene moxeparvovec-rokl kit, showing NDC number 60923-520-29, barcode, and spaces for serial number, lot number, and expiration date. The kit contents mention 29 vials of 10 mL each and 29 alcohol swabs, intended for intravenous use by patients weighing 28.5 to 29.4 kg. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 30 Count Carton Label (Ele03 0003 22)

Principal Display Panel -10 mL 30 Count Carton Label (Ele03 0003 22)
Packaging label for ELEVIDYS KIT containing delandistrogene moxeparvovec-rokl. The label shows a barcode, GTIN, serial number, lot number, and expiration date placeholders. It specifies patient weight range and kit contents including 30 vials of 10 mL each and 30 alcohol swabs. The label is from Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 31 Count Carton Label (Ele03 0003 23)

Principal Display Panel -10 mL 31 Count Carton Label (Ele03 0003 23)
ELEVIDYS kit label showing the nonproprietary name delandistrogene moxeparvovec-rokl, with package details including patient weight range of 30.5 to 31.4 kg, kit contents of 31 vials of 10 mL each, and 31 alcohol swabs. Barcode and placeholder information for GTIN, serial number, lot number, and expiration date are also visible. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 32 Count Carton Label (Ele03 0003 24)

Principal Display Panel -10 mL 32 Count Carton Label (Ele03 0003 24)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes a barcode, GTIN, lot number, and expiration details fields. It specifies kit contents including 32 10 mL vials and 32 alcohol swabs, and notes patient weight range from 31.5 to 32.4 kg. The labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 33 Count Carton Label (Ele03 0003 25)

Principal Display Panel -10 mL 33 Count Carton Label (Ele03 0003 25)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label shows NDC 60923-524-33, patient weight range 32.5-33.4 kg, and kit contents including 33 vials of 10 mL each and 33 alcohol swabs. The label also features barcodes and placeholders for lot and expiration dates. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 34 Count Carton Label (Ele03 0003 26)

Principal Display Panel -10 mL 34 Count Carton Label (Ele03 0003 26)
Label of the ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label includes patient weight range 33.5 - 34.4 kg and kit contents of 34 vials of 10 mL each plus 34 alcohol swabs. It displays a barcode, GTIN, serial number, lot number, and an expiration date field. The labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 35 Count Carton Label (Ele03 0003 27)

Principal Display Panel -10 mL 35 Count Carton Label (Ele03 0003 27)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label indicates patient weight range 34.5 to 35.4 kg and kit contents of 35 vials of 10 mL each, plus 35 alcohol swabs. It features a barcode, GTIN, serial number, lot, and expiration date placeholders, along with a refrigeration date box and FPO mark. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 36 Count Carton Label (Ele03 0003 28)

Principal Display Panel -10 mL 36 Count Carton Label (Ele03 0003 28)
Label panel for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. Displays NDC 60923-527-36 and indicates kit contents include 36 vials of 10 mL each plus 36 alcohol swabs. Barcode and placeholders for serial number, lot number, expiration date, and refrigeration date are also visible. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 37 Count Carton Label (Ele03 0003 29)

Principal Display Panel -10 mL 37 Count Carton Label (Ele03 0003 29)
Packaging label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, indicated for intravenous use. The label shows the product name, NDC number 60923-528-37, and barcode. It includes kit contents such as 37 vials of 10 mL and 37 alcohol swabs, patient weight range 36.5 to 37.4 kg, and placeholders for lot number, expiration date, and refrigeration date. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 38 Count Carton Label (Ele03 0003 30)

Principal Display Panel -10 mL 38 Count Carton Label (Ele03 0003 30)
Label for ELEVIDYS kit featuring the generic name delandistrogene moxeparvovec-rokl. The label includes patient weight range (37.5 - 38.4 kg) and kit contents listing 38 vials of 10 mL each plus 38 alcohol swabs. It shows a barcode, space for refrigeration date, and product identification codes. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 39 Count Carton Label (Ele03 0003 31)

Principal Display Panel -10 mL 39 Count Carton Label (Ele03 0003 31)
Label for ELEVIDYS containing the active ingredient delandistrogene moxeparvovec-rokl. The label includes a barcode with NDC number 60923-530-39, kit contents mentioning 39 vials of 10 mL and 39 alcohol swabs, patient weight range of 38.5 to 39.4 kg, and placeholders for lot number, serial number, expiration date, and date of refrigeration. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 40 Count Carton Label (Ele03 0003 32)

Principal Display Panel -10 mL 40 Count Carton Label (Ele03 0003 32)
Packaging label for ELEVIDYS KIT containing delandistrogene moxeparvovec-rokl for intravenous use. The label shows patient weight range (39.5 - 40.4 kg) and kit contents including 40 vials of 10 mL each and 40 alcohol swabs. It includes barcode, GTIN, serial number, lot number, and expiration date placeholder. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 41 Count Carton Label (Ele03 0003 33)

Principal Display Panel -10 mL 41 Count Carton Label (Ele03 0003 33)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes barcode and matrix code, GTIN number, serial and lot numbers, and placeholders for expiration and refrigeration dates. Kit contents note 41 vials of 10 mL each and 41 alcohol swabs for patient weight range 40.5-41.4 kg. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 42 Count Carton Label (Ele03 0003 34)

Principal Display Panel -10 mL 42 Count Carton Label (Ele03 0003 34)
ELEVIDYS delandistrogene moxeparvovec-rokl kit packaging label includes barcode and lot, serial number, expiration date placeholders. It specifies patient weight range (41.5 - 42.4 kg) and kit contents as 42 x 10 mL vials and 42 alcohol swabs. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 43 Count Carton Label (Ele03 0003 35)

Principal Display Panel -10 mL 43 Count Carton Label (Ele03 0003 35)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, intended for intravenous use. The label includes the NDC number 60923-534-43, GTIN, lot, expiration placeholders, and kit contents of 43 ten mL vials with 43 alcohol swabs. Also shown are a barcode and a QR code labeled FPO, with space for date of refrigeration and patient weight range (42.5 to 43.4 kg). Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 44 Count Carton Label (Ele03 0003 36)

Principal Display Panel -10 mL 44 Count Carton Label (Ele03 0003 36)
Label section for ELEVIDYS (delandistrogene moxeparvovec-rokl) kit indicating patient weight range of 43.5 to 44.4 kg. Kit contents include 44 vials of 10 mL each and 44 alcohol swabs. The label also shows a barcode, GTIN, serial number, lot number, and placeholder for expiration date and date of refrigeration. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 45 Count Carton Label (Ele03 0003 37)

Principal Display Panel -10 mL 45 Count Carton Label (Ele03 0003 37)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl, an intravenous human prescription drug by Sarepta Therapeutics, Inc. The label displays the NDC code 60923-536-45, barcode, patient weight range of 44.5 to 45.4 kg, and kit contents including 45 vials of 10 mL each and 45 alcohol swabs. Also features placeholders for lot number, serial number, expiration date, and refrigeration date.*
FDA Label Image

Principal Display Panel -10 mL 46 Count Carton Label (Ele03 0003 38)

Principal Display Panel -10 mL 46 Count Carton Label (Ele03 0003 38)
Label from ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label shows the NDC 60923-537-46, patient weight range (45.5-46.4 kg), and kit contents of 46 x 10 mL vials plus 46 alcohol swabs. It includes a barcode, GTIN, serial number, lot number, and expiration date fields. The labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 47 Count Carton Label (Ele03 0003 39)

Principal Display Panel -10 mL 47 Count Carton Label (Ele03 0003 39)
Label of ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label includes the NDC number 60923-538-47, patient weight range 46.5 to 47.4 kg, and kit contents listing 47 vials of 10 mL each and 47 alcohol swabs. It displays barcodes and placeholders for lot and expiration dates, labeled with the manufacturer Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 48 Count Carton Label (Ele03 0003 40)

Principal Display Panel -10 mL 48 Count Carton Label (Ele03 0003 40)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label displays the NDC 60923-539-48, patient weight range 47.5 to 48.4 kg, and kit contents including 48 ten-milliliter vials and 48 alcohol swabs. It also features a barcode, GTIN, serial number, lot number, and an area designated for the date of refrigeration.*
FDA Label Image

Principal Display Panel -10 mL 49 Count Carton Label (Ele03 0003 41)

Principal Display Panel -10 mL 49 Count Carton Label (Ele03 0003 41)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes patient weight range, kit contents with 49 vials and 49 alcohol swabs, barcode, 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 50 Count Carton Label (Ele03 0003 42)

Principal Display Panel -10 mL 50 Count Carton Label (Ele03 0003 42)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes patient weight range 49.5 - 50.4 kg and specifies kit contents as 50 vials of 10 mL each plus 50 alcohol swabs. Also visible are barcodes, a section for date of refrigeration, and placeholders for serial number, lot number, and expiration date. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel –carton Kit Label (Ele03 0003 43)

Principal Display Panel –carton Kit Label (Ele03 0003 43)
Packaging label for ELEVIDYS (delandistrogene moxeparvovec-rokl) kit for intravenous use. The label specifies a concentration of 1.33 x 10^13 vector genomes/mL as a suspension for infusion. It includes storage instructions, noting to keep unopened vials at -60°C (-76°F) in the original carton with refrigeration allowed for up to 14 days at 2°C to 8°C (36°F to 46°F). Marked for single patient use, preservative-free. Manufactured by Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel –carton Kit Label (Ele03 0003 44)

Principal Display Panel –carton Kit Label (Ele03 0003 44)
The image shows the packaging label for ELEVIDYS, containing delandistrogene moxeparvovec-rokl suspension for infusion. It highlights the concentration of 1.33 x 10^13 vector genomes/mL for intravenous use. The label includes storage instructions, usage notes such as single patient use and preservative-free status, and states the product is manufactured by Sarepta Therapeutics, Inc. The Sarepta logo is displayed prominently on the label.*
FDA Label Image

Principal Display Panel –vial Label (Ele03 0003 45)

Principal Display Panel –vial Label (Ele03 0003 45)
Label for ELEVIDYS (delandistrogene moxeparvovec-rokl) suspension for infusion, 1.33 x 10¹³ vector genomes/mL in a single-dose 10 mL vial. The label indicates intravenous use with storage at or below -60°C (-76°F), manufactured by Sarepta Therapeutics, Inc., Cambridge, MA.*
FDA Label Image

Principal Display Panel -10 mL 51 Count Carton Label (Ele03 0003 46)

Principal Display Panel -10 mL 51 Count Carton Label (Ele03 0003 46)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl by Sarepta Therapeutics, Inc. Shows NDC 60923-542-51 with barcode and kit details including patient weight range 50.5 - 51.4 kg. Kit contents list 51 vials of 10 mL and 51 alcohol swabs. Includes placeholders for serial number, lot number, expiration date, and refrigeration date.*
FDA Label Image

Principal Display Panel -10 mL 52 Count Carton Label (Ele03 0003 47)

Principal Display Panel -10 mL 52 Count Carton Label (Ele03 0003 47)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label includes NDC 60923-543-52, patient weight range 51.5 to 52.4 kg, and kit contents of 52 vials of 10 mL plus 52 alcohol swabs. Manufacturer is Sarepta Therapeutics, Inc. Barcodes and placeholders for lot number and expiration date are present.*
FDA Label Image

Principal Display Panel -10 mL 53 Count Carton Label (Ele03 0003 48)

Principal Display Panel -10 mL 53 Count Carton Label (Ele03 0003 48)
Label for ELEVIDYS (delandistrogene moxeparvovec-rokl) human prescription drug kit for intravenous use by Sarepta Therapeutics, Inc. The label includes patient weight range (52.5 - 53.4 kg), kit contents listing 53 x 10 mL vials and 53 alcohol swabs, barcodes, GTIN, serial number, lot number, and expiration date placeholders, along with a date of refrigeration box.*
FDA Label Image

Principal Display Panel -10 mL 54 Count Carton Label (Ele03 0003 49)

Principal Display Panel -10 mL 54 Count Carton Label (Ele03 0003 49)
Label for ELEVIDYS (delandistrogene moxeparvovec-rokl) kit, a human prescription drug by Sarepta Therapeutics, Inc. The label includes NDC 60923-545-54, barcode, and placeholders for lot number, serial number, expiration date, and date of refrigeration. Kit contents list 54 vials of 10 mL each and 54 alcohol swabs, for patient weight 53.5 to 54.4 kg.*
FDA Label Image

Principal Display Panel -10 mL 55 Count Carton Label (Ele03 0003 50)

Principal Display Panel -10 mL 55 Count Carton Label (Ele03 0003 50)
Label panel for ELEVIDYS kit, containing delandistrogene moxeparvovec-rokl for intravenous use. The label shows NDC 60923-546-55, a barcode, GTIN, lot, and expiration placeholders. It notes kit contents of 55 vials of 10 mL each and 55 alcohol swabs, intended for patients weighing 54.5-55.4 kg. The labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 56 Count Carton Label (Ele03 0003 51)

Principal Display Panel -10 mL 56 Count Carton Label (Ele03 0003 51)
Label for ELEVIDYS (delandistrogene moxeparvovec-rokl) human prescription drug kit. The label includes barcode, generic and proprietary names, patient weight range (55.5 - 56.4 kg), and kit contents listing 56 x 10 mL vials and 56 alcohol swabs. Labeler is Sarepta Therapeutics, Inc. Date of refrigeration and lot number fields are blank.*
FDA Label Image

Principal Display Panel -10 mL 57 Count Carton Label (Ele03 0003 52)

Principal Display Panel -10 mL 57 Count Carton Label (Ele03 0003 52)
Packaging label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label includes patient weight range (56.5 - 57.4 kg), kit contents of 57 vials of 10 mL each, and 57 alcohol swabs. It displays barcodes, GTIN, serial number, lot number, and expiration date placeholders. The label is marked with the NDC 60923-548-57.*
FDA Label Image

Principal Display Panel -10 mL 58 Count Carton Label (Ele03 0003 53)

Principal Display Panel -10 mL 58 Count Carton Label (Ele03 0003 53)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes an NDC barcode with code 60923-549-58, a placeholder for patient weight (57.5-58.4 kg), kit contents listing 58 x 10 mL vials and 58 alcohol swabs, and fields for GTIN, serial number, lot number, expiration date, and refrigeration date. The label is from Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 59 Count Carton Label (Ele03 0003 54)

Principal Display Panel -10 mL 59 Count Carton Label (Ele03 0003 54)
Packaging label for ELEVIDYS kit featuring the active ingredient delandistrogene moxeparvovec-rokl. The label includes a barcode, GTIN number, lot number, expiration date placeholder, and kit contents specifying 59 vials of 10 mL each and 59 alcohol swabs. It also notes patient weight range of 58.5 to 59.4 kg and refrigeration date box. Labeler information is not shown in the image.*
FDA Label Image

Principal Display Panel -10 mL 60 Count Carton Label (Ele03 0003 55)

Principal Display Panel -10 mL 60 Count Carton Label (Ele03 0003 55)
Label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label includes patient weight range, kit contents listing 60 vials of 10 mL and 60 alcohol swabs, a barcode, and fields for GTIN, serial number, lot number, and expiration date. The label shows it is for intravenous use and is distributed by Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 61 Count Carton Label (Ele03 0003 56)

Principal Display Panel -10 mL 61 Count Carton Label (Ele03 0003 56)
Packaging label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl. The label indicates that the kit is for intravenous use and includes 61 vials of 10 mL each plus 61 alcohol swabs. The label shows the NDC 60923-552-61, GTIN barcode, and placeholders for lot number, expiration date, and refrigeration date. The labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 62 Count Carton Label (Ele03 0003 57)

Principal Display Panel -10 mL 62 Count Carton Label (Ele03 0003 57)
Packaging label for ELEVIDYS (delandistrogene moxeparvovec-rokl) kit, an intravenous human prescription drug by Sarepta Therapeutics, Inc. The label includes the NDC code 60923-553-62, barcode, placeholders for serial number, lot number, and expiration date, and kit contents listing 62 vials of 10 mL and 62 alcohol swabs for patient weight 61.5-62.4 kg.*
FDA Label Image

Principal Display Panel -10 mL 63 Count Carton Label (Ele03 0003 58)

Principal Display Panel -10 mL 63 Count Carton Label (Ele03 0003 58)
Label panel for ELEVIDYS (delandistrogene moxeparvovec-rokl) kit shows the NDC 60923-554-63, barcode, and GTIN number. The kit is for intravenous use and includes 63 vials of 10 mL each plus 63 alcohol swabs. There is a space for recording the date of refrigeration. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 64 Count Carton Label (Ele03 0003 59)

Principal Display Panel -10 mL 64 Count Carton Label (Ele03 0003 59)
Packaging label for ELEVIDYS, containing the nonproprietary name delandistrogene moxeparvovec-rokl. The label includes a barcode and mentions kit contents with 64 vials of 10 mL each and 64 alcohol swabs. It provides space for patient weight, date of refrigeration, lot number, and expiration date placeholders. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 65 Count Carton Label (Ele03 0003 60)

Principal Display Panel -10 mL 65 Count Carton Label (Ele03 0003 60)
ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use by Sarepta Therapeutics, Inc. The label includes a barcode, a QR code marked FPO, placeholders for lot number, serial number, and expiration date, and notes kit contents: 65 vials of 10 mL and 65 alcohol swabs, for patients weighing 64.5 to 65.4 kg.*
FDA Label Image

Principal Display Panel -10 mL 66 Count Carton Label (Ele03 0003 61)

Principal Display Panel -10 mL 66 Count Carton Label (Ele03 0003 61)
Label for ELEVIDYS (delandistrogene moxeparvovec-rokl) human prescription drug kit by Sarepta Therapeutics, Inc. The label includes NDC code 60923-557-66, barcodes, placeholders for serial number, lot number, and expiration date. Kit contents note 66 x 10 mL vials and 66 alcohol swabs for patient weight 65.5-66.4 kg. Refrigeration date box is present but empty.*
FDA Label Image

Principal Display Panel -10 mL 67 Count Carton Label (Ele03 0003 62)

Principal Display Panel -10 mL 67 Count Carton Label (Ele03 0003 62)
Packaging label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes barcode, GTIN, serial number, lot number placeholder, and expiration date placeholder. It specifies patient weight range (66.5-67.4 kg) and kit contents of 67 vials of 10 mL each plus 67 alcohol swabs. Labeler name Sarepta Therapeutics, Inc. is implied by product data but not visible on label.*
FDA Label Image

Principal Display Panel -10 mL 68 Count Carton Label (Ele03 0003 63)

Principal Display Panel -10 mL 68 Count Carton Label (Ele03 0003 63)
Packaging label for ELEVIDYS kit containing delandistrogene moxeparvovec-rokl for intravenous use. The label includes the NDC 60923-559-68 and indicates kit contents of 68 vials of 10 mL each plus 68 alcohol swabs. The label shows placeholders for lot number, expiration date, and refrigeration date, along with barcodes and GTIN information. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 69 Count Carton Label (Ele03 0003 64)

Principal Display Panel -10 mL 69 Count Carton Label (Ele03 0003 64)
Label for ELEVIDYS (delandistrogene moxeparvovec-rokl) intravenous kit. The label includes patient weight range 68.5-69.4 kg, kit contents listing 69 x 10 mL vials and 69 alcohol swabs, barcode, and placeholders for lot number, expiration date, and date of refrigeration. Labeler is Sarepta Therapeutics, Inc.*
FDA Label Image

Principal Display Panel -10 mL 70 Count Carton Label (Ele03 0003 65)

Principal Display Panel -10 mL 70 Count Carton Label (Ele03 0003 65)
Packaging label for ELEVIDYS (delandistrogene moxeparvovec-rokl) kit by Sarepta Therapeutics, Inc. The label includes NDC code 60923-561-70, space for lot number, expiration date, and date of refrigeration. It mentions kit contents as 70 x 10 mL vials and 70 alcohol swabs, with an intravenous route and patient weight 69.5 kg and above.*

* 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.