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NDC 60923-0561-70 ELEVIDYS Details

ELEVIDYS

ELEVIDYS is a INTRAVENOUS KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sarepta Therapeutics, Inc.. The primary component is .

MedlinePlus Drug Summary

Delandistrogene moxeparvovec-rokl injection is used to treat Duchenne muscular dystrophy (DMD; a progressive disease in which the muscles do not function properly) in certain children 4 through 5 years of age. It is in a class of medications called gene therapy. It works by replacing a defective gene in muscles which helps improve muscle function.

Related Packages: 60923-0561-70
Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Delandistrogene moxeparvovec-rokl Injection

Product Information

NDC	60923-0561
Product ID	60923-561_80df21b6-b985-4b52-af98-e4da9506954a
Associated GPIs
GCN Sequence Number	084970
GCN Sequence Number Description	delandistrogene moxeparvc-rokl KIT 1.33X10E13 INTRAVEN
HIC3	Z16
HIC3 Description	GENE THERAPY AGENTS - PROTEIN DEFICIENCY
GCN	54395
HICL Sequence Number	049019
HICL Sequence Number Description	DELANDISTROGENE MOXEPARVOVEC-ROKL
Brand/Generic	Brand
Proprietary Name	ELEVIDYS
Proprietary Name Suffix	n/a
Non-Proprietary Name	delandistrogene moxeparvovec-rokl
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	KIT
Route	INTRAVENOUS
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Sarepta Therapeutics, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	BLA
Application Number	BLA125781
Listing Certified Through	2024-12-31

Package

NDC 60923-0561-70 (60923056170)

Pricing Information	N/A
NDC Package Code	60923-561-70
Billing NDC	60923056170
Package	1 KIT in 1 CARTON (60923-561-70) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 70 POUCH in 1 BOX / 1 SWAB in 1 POUCH
Marketing Start Date	2023-06-22
NDC Exclude Flag	N