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 83 of 85 · 1,682 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cardioplegic	CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDE	Baxter Healthcare Corporation	1fd50ce5-2799-4c26-81da-02cf0578dd9e	2020-06-11	Warnings, Adverse reactions	Exact identifier unii: 02F3473H9O unii: 451W47IQ8X
0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a62b71db-8ba2-6f6b-e053-2a95a90a29d1	2020-05-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
LACTATED RINGERS AND DEXTROSE	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE	HF Acquisition Co LLC, DBA HealthFirst	a62cf623-9b8a-37e0-e053-2995a90add5b	2020-05-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Hay Fever	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, ALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AMMONIUM CARBONICUM, ARALIA RACEMOSA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CISTUS CANADENSIS, DROSERA, DULCAMARA, EUPATORIUM PERFOLIATUM, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS	Newton Laboratories, Inc.	a6045b91-d361-2731-e053-2a95a90a9772	2020-05-18	Warnings	Exact identifier unii: 451W47IQ8X
DEXTROSE AND SODIUM CHLORIDE	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE	Fresenius Kabi USA, LLC	b825c9c4-f2fb-4a4a-9d8c-fb020ad07e93	2020-04-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a2b8220f-e33a-51c3-e053-2995a90a0734	2020-04-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a2bba76a-08ce-6902-e053-2995a90ab9c9	2020-04-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dextrose and Electrolyte No. 48	SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATE	Baxter Healthcare Company	b283a454-0c20-4fbf-92d3-dae1f3cd3cad	2020-02-13	Warnings, Adverse reactions	Exact identifier unii: 02F3473H9O unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	fbc01464-8885-4075-af41-911ffec5ae92	2020-01-27	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Baxter Healthcare Company	8bcf5572-49e1-4302-9522-56f57904cb4a	2019-12-29	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Plasma-Lyte A	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Baxter Healthcare Corporation	6ec9e61c-2c26-402f-8604-f446b2e34058	2019-08-05	Warnings, Adverse reactions	Exact identifier unii: 02F3473H9O unii: 451W47IQ8X
Dukal Sterile Alcohol Prep Pad	ISOPROPYL ALCOHOL	Dukal Corporation	54586d75-a0a1-46aa-9cc9-631094320bff	2019-02-28	Warnings	Exact identifier rxcui: 797544 unii: ND2M416302
Potassium Chloride in Dextrose and Sodium Chloride	POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	Baxter Healthcare Company	c553fed1-3de5-4826-8eff-633b5923bf0b	2019-02-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Sodium Chloride	POTASSIUM CHLORIDE AND SODIUM CHLORIDE	Baxter Healthcare Company	becc7410-0a25-49f5-b0c3-240078479dc8	2019-01-11	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Skin Klear Acne Relief	TRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLOR	Homeocare Laboratories	65afbc20-611b-4bc4-a151-c633bec66a82	2018-12-31	Warnings	Exact identifier unii: 451W47IQ8X
H.M.D.	ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOM	Zorex International	8c53091a-904d-4756-93e4-17143c5b48e9	2018-12-21	Warnings	Exact identifier unii: 451W47IQ8X
Vitality Female	ARALIA QUINQUEFOLIA, AVENA SATIVA, BERBERIS VULGARIS, CAUSTICUM, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA	Natural Creations, Inc	679ba86d-bf84-4ded-b0bf-d55a0df9faa4	2018-12-21	Warnings	Exact identifier unii: 451W47IQ8X
Hydrate II	BERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUA	Zorex International	e5f53495-3b75-4d7c-89af-23058fb6fd05	2018-12-21	Warnings	Exact identifier unii: 451W47IQ8X
Dynamic Eyewash with Eyecup	WATER	Dynamic Safety International	7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2	2018-12-17	Warnings	Exact identifier unii: 059QF0KO0R
WinCo Foods Saline Nasal Relief	SODIUM CHLORIDE	WinCo Foods, LLC	1280fee4-e763-49ba-8722-8cdb8157f1a4	2018-08-02	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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