FDA.reportPublic FDA data

NDC 60923-563 - 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
60923-563
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
LabelManufacturerEffective dateType
ELEVIDYS - Sarepta Therapeutics, Inc.Sarepta Therapeutics, Inc.2026-08-12HUMAN PRESCRIPTION DRUG LABEL

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 4 of 89 · 1,774 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM59 DROPSCALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCCBM Private Limited58ef0755-c2cd-b7c2-e063-6294a90a27072026-08-13WarningsExact identifier
unii: 451W47IQ8X
ELEVIDYSDELANDISTROGENE MOXEPARVOVEC-ROKLSarepta Therapeutics, Inc.3525abcd-fbd2-46c5-9706-cffdf2e8a3612026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125781
ndc (package): 60923-557-66
ndc (package): 60923-513-22
ndc (package): 60923-516-25
ndc (package): 60923-546-55
ndc (package): 60923-508-17
ndc (package): 60923-539-48
ndc (package): 60923-504-13
ndc (package): 60923-509-18
ndc (package): 60923-540-49
ndc (package): 60923-520-29
ndc (package): 60923-517-26
ndc (package): 60923-558-67
ndc (package): 60923-556-65
ndc (package): 60923-541-50
ndc (package): 60923-548-57
ndc (package): 60923-506-15
ndc (package): 60923-554-63
ndc (package): 60923-561-70
ndc (package): 60923-553-62
ndc (package): 60923-560-69
ndc (package): 60923-505-14
ndc (package): 60923-536-45
ndc (package): 60923-551-60
ndc (package): 60923-552-61
ndc (package): 60923-543-52
ndc (package): 60923-510-19
ndc (package): 60923-535-44
ndc (package): 60923-514-23
ndc (package): 60923-525-34
ndc (package): 60923-545-54
ndc (package): 60923-530-39
ndc (package): 60923-550-59
ndc (package): 60923-538-47
ndc (package): 60923-532-41
ndc (package): 60923-502-11
ndc (package): 60923-515-24
ndc (package): 60923-521-30
ndc (package): 60923-534-43
ndc (package): 60923-507-16
ndc (package): 60923-555-64
ndc (package): 60923-544-53
ndc (package): 60923-537-46
ndc (package): 60923-512-21
ndc (package): 60923-528-37
ndc (package): 60923-526-35
ndc (package): 60923-518-27
ndc (package): 60923-523-32
ndc (package): 60923-547-56
ndc (package): 60923-562-01
ndc (package): 60923-524-33
ndc (package): 60923-522-31
ndc (package): 60923-549-58
ndc (package): 60923-533-42
ndc (package): 60923-531-40
ndc (package): 60923-501-10
ndc (package): 60923-519-28
ndc (package): 60923-511-20
ndc (package): 60923-503-12
ndc (package): 60923-559-68
ndc (package): 60923-527-36
ndc (package): 60923-542-51
ndc (package): 60923-529-38
ndc (product): 60923-520
ndc (product): 60923-517
ndc (product): 60923-521
ndc (product): 60923-542
ndc (product): 60923-513
ndc (product): 60923-516
ndc (product): 60923-536
ndc (product): 60923-522
ndc (product): 60923-531
ndc (product): 60923-538
ndc (product): 60923-556
ndc (product): 60923-512
ndc (product): 60923-518
ndc (product): 60923-533
ndc (product): 60923-523
ndc (product): 60923-501
ndc (product): 60923-530
ndc (product): 60923-544
ndc (product): 60923-559
ndc (product): 60923-510
ndc (product): 60923-546
ndc (product): 60923-508
ndc (product): 60923-537
ndc (product): 60923-541
ndc (product): 60923-515
ndc (product): 60923-525
ndc (product): 60923-552
ndc (product): 60923-504
ndc (product): 60923-550
ndc (product): 60923-561
ndc (product): 60923-505
ndc (product): 60923-527
ndc (product): 60923-560
ndc (product): 60923-558
ndc (product): 60923-539
ndc (product): 60923-553
ndc (product): 60923-551
ndc (product): 60923-528
ndc (product): 60923-511
ndc (product): 60923-526
ndc (product): 60923-514
ndc (product): 60923-543
ndc (product): 60923-549
ndc (product): 60923-507
ndc (product): 60923-524
ndc (product): 60923-529
ndc (product): 60923-509
ndc (product): 60923-502
ndc (product): 60923-535
ndc (product): 60923-503
ndc (product): 60923-557
ndc (product): 60923-545
ndc (product): 60923-554
ndc (product): 60923-555
ndc (product): 60923-534
ndc (product): 60923-519
ndc (product): 60923-548
ndc (product): 60923-540
ndc (product): 60923-532
ndc (product): 60923-547
ndc (product): 60923-506
rxcui: 2641701
rxcui: 2641787
rxcui: 2641771
rxcui: 2641704
rxcui: 2641738
rxcui: 2641730
rxcui: 2641763
rxcui: 2641760
rxcui: 2641759
rxcui: 2641696
rxcui: 2641747
rxcui: 2641707
rxcui: 2641782
rxcui: 2641780
rxcui: 2641708
rxcui: 2641741
rxcui: 2641710
rxcui: 2641838
rxcui: 2641761
rxcui: 2641725
rxcui: 2641789
rxcui: 2641756
rxcui: 2641778
rxcui: 2641720
rxcui: 2641692
rxcui: 2641768
rxcui: 2641722
rxcui: 2641715
rxcui: 2641745
rxcui: 2641705
rxcui: 2641735
rxcui: 2641753
rxcui: 2641750
rxcui: 2641690
rxcui: 2641689
rxcui: 2641755
rxcui: 2641849
rxcui: 2641726
rxcui: 2641723
rxcui: 2641845
rxcui: 2641762
rxcui: 2641736
rxcui: 2641719
rxcui: 2641688
rxcui: 2641833
rxcui: 2641840
rxcui: 2641773
rxcui: 2641835
rxcui: 2641752
rxcui: 2641699
rxcui: 2641758
rxcui: 2641754
rxcui: 2641706
rxcui: 2641717
rxcui: 2641751
rxcui: 2641839
rxcui: 2641724
rxcui: 2641834
rxcui: 2641764
rxcui: 2641679
rxcui: 2641727
rxcui: 2641765
rxcui: 2641729
rxcui: 2641844
rxcui: 2641695
rxcui: 2641712
rxcui: 2641777
rxcui: 2641694
rxcui: 2641837
rxcui: 2641776
rxcui: 2641746
rxcui: 2641743
rxcui: 2641774
rxcui: 2641713
rxcui: 2641779
rxcui: 2641785
rxcui: 2641841
rxcui: 2641832
rxcui: 2641836
rxcui: 2641772
rxcui: 2641733
rxcui: 2641732
rxcui: 2641709
rxcui: 2641781
rxcui: 2641769
rxcui: 2641702
rxcui: 2641766
rxcui: 2641711
rxcui: 2641748
rxcui: 2641775
rxcui: 2641698
rxcui: 2641770
rxcui: 2641742
rxcui: 2641846
rxcui: 2641831
rxcui: 2641757
rxcui: 2641728
rxcui: 2641842
rxcui: 2641848
rxcui: 2641737
rxcui: 2641721
rxcui: 2641693
rxcui: 2641703
rxcui: 2641767
rxcui: 797544
rxcui: 2641784
rxcui: 2641716
rxcui: 2641740
rxcui: 2641714
rxcui: 2641788
rxcui: 2641786
rxcui: 2641744
rxcui: 2641700
rxcui: 2641687
rxcui: 2641739
rxcui: 2641685
rxcui: 2641691
rxcui: 2641843
rxcui: 2641783
rxcui: 2641830
rxcui: 2641734
rxcui: 2641697
rxcui: 2641718
rxcui: 2641847
rxcui: 2641731
spl id: a96a4f2b-47a9-4175-b3c4-78a0c9350a09
spl set id: 3525abcd-fbd2-46c5-9706-cffdf2e8a361
Adrenal-ToneADRENALINUM, AVENA, GINKGO, GLYCYRRHIZA, KALI PHOS, NAT MUR, NUX VOMICA, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SARSAPARILLA, THYROIDINUM, VERATRUM ALB, ZINC MET.Energetix Corporation1ea4abb3-3a02-4d5c-baeb-d903b0febbb52026-08-11WarningsExact identifier
unii: 451W47IQ8X
AdrenapathCARDUUS MARIANUS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM (BOVINE), THYROIDINUM (BOVINE)Energetix Corporationc300b8f5-4334-4597-a303-8200cbc117d12026-08-11WarningsExact identifier
unii: 451W47IQ8X
LUXURY IPA 70%LUXURY ISOPROPYL ALCOHOL 70% 16OZTSM BRANDS LLC2240a9e0-dac5-54fa-e063-6394a90a35f52026-08-11WarningsExact identifier
unii: ND2M416302
Hepatic-ToneCARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CITRICUM ACIDUM, CYSTEINUM, HEPAR SUIS, LEPTANDRA VIRGINICA, MAGNESIA MURIATICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUASSIA (AMARA), TARAXACUM OFFICINALEEnergetix Corporationd5f61f13-7e9f-4e46-8ad8-0336f36288df2026-08-11WarningsExact identifier
unii: 02F3473H9O
Lymph-Tone IIAESCULUS HIPP, AZADIRACHTA, BARYTA CARB, BERBER VULG, BOLDO, BUFO, CALC CARB, CALC PHOS, COENZYME A, COLLINSONIA, ECHINACEA, FERRUM PHOS, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KREOSOTUM, NADIDUM, NAT MUR, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PIX LIQUIDA, PULSATILLA, SILICEA, STILLINGIA, THUJA OCC.Energetix Corporationc46aa8d3-4aa5-4e07-be3d-d71abc5e24072026-08-11WarningsExact identifier
unii: 451W47IQ8X
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: 451W47IQ8X
Tox-ChordALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.Energetix Corporationb06b4794-e5bb-4ccd-87fd-37afca7b0f982026-08-11WarningsExact identifier
unii: 451W47IQ8X
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: 451W47IQ8X
ABRILADAADALIMUMAB-AFZBA-S Medication Solutions1602cfaf-9ddd-4eb6-b847-10a4eebcf5e52026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
LIGHTS Antiseptic and Pain Relieving Prep PadISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.91cc7334-f610-487d-a895-3dda78c3372e2026-08-07WarningsExact identifier
unii: ND2M416302
CVS Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLCVS Pharmacy524605f9-8b04-b600-e063-6394a90a4a022026-08-07WarningsExact identifier
unii: ND2M416302
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Isopropyl alcohol 70 percent ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLC57c496b3-10ab-4a72-8d8f-42a2256189dd2026-08-06WarningsExact identifier
unii: ND2M416302
PROHEAL ALCOHOL PREP PADSISOPROPYL ALCOHOLClick Industries LLCd272c1f6-e9c9-4099-9d24-f5aae44082ae2026-08-05WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Tazza Antiseptic Hand WipesISOPROPYL ALCOHOLTazza Brands East Inc.c37c7599-58b6-58bb-e053-2a95a90af1cf2026-08-04WarningsExact identifier
unii: ND2M416302
MetabatoneARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM,Energique, Inc.9510bb76-b717-407d-b9e8-da7743e4cfc82026-07-31WarningsExact identifier
unii: 451W47IQ8X
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADVOCATE Sterile Alcohol Prep PadsISOPROPYL ALCOHOLPHARMA SUPPLY, INCa87dd40d-a9b1-4bb5-acc2-2d00abc2034a2026-07-30WarningsExact identifier
rxcui: 797544
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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