NDC 60923-562-01 - ELEVIDYS

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 60923-562
Requested NDC: 60923-562-01
Package NDCs from labels: 60923-562-01
Manufacturer: Sarepta Therapeutics, Inc.
Effective date: 2026-08-12
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ELEVIDYS - Sarepta Therapeutics, Inc.	Sarepta Therapeutics, Inc.	2026-08-12	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	290 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	610 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	700 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	120 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	210 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	180 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	440 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	540 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	660 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	450 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	570 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	150 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	330 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	310 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	460 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	590 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	640 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	370 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	520 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	420 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	510 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	530 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	100 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	130 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	320 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	580 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	500 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	230 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	350 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	280 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	480 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	430 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	110 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	670 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	410 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	140 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	270 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	220 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	340 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	680 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	240 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	300 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	470 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	560 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	400 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	390 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	490 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	170 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	250 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	600 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	260 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	650 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	380 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	620 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	690 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	360 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	630 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	550 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	160 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	200 mL	13300000000000 {GC} in 1mL	11
60923-562-01	ELEVIDYS	10 mL in 1 VIAL, SINGLE-USE	INJECTION, SUSPENSION	190 mL	13300000000000 {GC} in 1mL	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60923-562	ELEVIDYS (DELANDISTROGENE MOXEPARVOVEC-ROKL) KIT [SAREPTA THERAPEUTICS, INC.]	10	Unmatched	20240907_3525abcd-fbd2-46c5-9706-cffdf2e8a361.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 35 of 86 · 1,715 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	85416361-90b5-3efa-e053-2a91aa0af431	2025-11-03	Warnings	Exact identifier unii: ND2M416302
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	8528a4f5-5ff4-45f3-e053-2991aa0a804c	2025-11-03	Warnings	Exact identifier unii: ND2M416302
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	ICU Medical Inc.	d8ee14e9-6733-4813-9f21-2b043a5f7188	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	ICU Medical Inc.	4555b1bf-6d97-4798-a63d-6d34291c85ce	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	ICU Medical Inc.	aab10f03-26ae-4dbc-a481-ef025e48b405	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	ICU Medical Inc.	9dd1c001-73b3-41d4-9a96-61f6ad3a5dc3	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	ICU Medical Inc.	e3484bc6-ed7f-43ef-9d49-c131a8dff2dd	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	3cfdeee0-ff14-4341-8396-b11c2a037c60	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	5f372b75-d7a4-471e-8ac6-290040fc84b0	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	ICU Medical Inc.	243fe8fc-996a-4855-8daf-069628e547c4	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE	ICU Medical Inc.	d310d170-5eeb-471b-af1a-0e845001d21d	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Simlandi	ADALIMUMAB-RYVK	Teva Pharmaceuticals USA, Inc.	12f609c9-2088-bb05-e063-6394a90a9ecc	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 797544
Family Care Saline	SODIUM CHLORIDE	United Exchange Corp.	06737393-d4ae-3e7b-e063-6394a90ac19f	2025-10-31	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	009bef3c-e8ac-46be-b564-a2556adf0081	2025-10-31	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE	ICU Medical Inc.	237b39fa-916e-4a54-99c8-4ae9ad54f056	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
ChloraPrep One-Step	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	CareFusion 213, LLC	8529596f-37e4-c44e-e053-2a91aa0ad014	2025-10-30	Warnings	Exact identifier unii: ND2M416302
Normosol-R and Dextrose	DEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	ICU Medical Inc.	ead1fca3-eff4-478f-8a8f-67510f80151a	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 02F3473H9O unii: 451W47IQ8X
Normosol-R	SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	ICU Medical Inc.	0e089a44-0cee-4804-8f6f-8508508ddb5c	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 02F3473H9O unii: 451W47IQ8X
Ionosol MB and Dextrose	DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	ICU Medical Inc.	1b457b1d-0e80-4578-ba6f-dedf513fc962	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 02F3473H9O
Normosol-R	SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	ICU Medical Inc.	189b8ac6-e346-454f-b501-7645590ca4f8	2025-10-29	Warnings, Adverse reactions	Exact identifier unii: 02F3473H9O unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.