FDA.reportPublic FDA data

NDC 71894-115 - Zolgensma

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
71894-115
Package NDCs from labels
71894-115-01
Manufacturer
Novartis Innovative Technologies Inc.
Effective date
2026-06-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zolgensma - Novartis Innovative Technologies Inc.Novartis Innovative Technologies Inc.2026-06-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION107.9 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION58.1 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION74.7 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION24.9 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION91.3 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION99.6 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION91.3 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION16.6 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION41.5 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION8.3 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION24.9 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION107.9 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION66.4 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION33.2 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION99.6 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION33.2 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION83 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION16.6 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION16.6 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION66.4 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION58.1 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION58.1 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION74.7 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION91.3 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION41.5 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION41.5 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION99.6 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION49.8 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION33.2 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION49.8 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION74.7 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION49.8 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION66.4 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION83 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION24.9 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION83 mL20000000000000 [arb'U] in 1mL14
71894-115-01Zolgensma8.3 mL in 1 VIALINJECTION, SUSPENSION116.2 mL20000000000000 [arb'U] in 1mL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71894-115ZOLGENSMA (ONASEMNOGENE ABEPARVOVEC-XIOI) KIT [NOVARTIS GENE THERAPIES, INC.]13Unmatched20250214_68cd4f06-70e1-40d8-bedb-609ec0afa471.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 14 of 89 · 1,774 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Chloride Normal SaltSODIUM CHLORIDETWIN MED LLC10230c8a-e5e5-44f1-b41d-80930899d6b92026-03-31WarningsExact identifier
unii: 451W47IQ8X
H-Allergy FormulaALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARUM TRIPHYLLUM, ARUNDO MAURITANICA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, NATRUM MURIATICUM, SOLIDAGO VIRGAUREA, STICTA PULMONARIA, SULPHUR, TRIFOLIUM PRATENSE, WYETHIA HELENIOIDESHealing Natural Oils LLC4e586360-b3c4-1ce0-e063-6394a90ab6b82026-03-31WarningsExact identifier
unii: 451W47IQ8X
Isopro First AidISOPROPYL ALCOHOLWater-Jel Technologiesf38563f5-ee54-4979-9157-4bf8fd60daab2026-03-31WarningsExact identifier
unii: ND2M416302
Acne HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMBioActive Nutritional, Inc.2ab4ff53-4274-40c7-b05c-44d918d809be2026-03-31WarningsExact identifier
unii: 451W47IQ8X
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM HYPOCHLOROUS, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.ad6a08ec-5eba-405b-8a07-79ac86ab3e7a2026-03-31WarningsExact identifier
unii: 451W47IQ8X
CirculatoneFAGOPYRUM ESCULENTUM, MAGNESIA MURIATICA, CITRUS BIOFLAVONOIDS, HEART (SUIS), THYROIDINUM (SUIS), ARSENICUM IODATUM, AURUM MURIATICUM, BARYTA MURIATICA, CALCAREA IODATA, CHOLESTERINUM, CONIUM MACULATUM, KALI IODATUM, PLUMBUM METALLICUM, ARNICA MONTANA, PHOSPHORUSBioActive Nutritional, Inc.465fb3c6-88e6-4099-a26a-33991ec5a1062026-03-31WarningsExact identifier
unii: 02F3473H9O
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4e404989-89d0-b189-e063-6394a90a8caa2026-03-30WarningsExact identifier
rxcui: 797544
unii: ND2M416302
MedPride Sterile Prep PadsISOPROPYL ALCOHOLShield Line LLC31de24d8-b70e-47f1-8946-6bd9fb16b5d52026-03-30WarningsExact identifier
rxcui: 797544
unii: ND2M416302
ANX HPARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUMBioActive Nutritional, Inc.96035891-aea3-4138-bb26-801ad819f6392026-03-30WarningsExact identifier
unii: 451W47IQ8X
Spleen LiquescenceQUERCUS ROBUR, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.d800456d-60f0-413d-b310-91b8b881f6b92026-03-30WarningsExact identifier
unii: 451W47IQ8X
leuprolide acetateLEUPROLIDE ACETATEUBI Pharma Inc.cd46628f-055f-4da9-8c38-fa69af34eb4d2026-03-29Warnings, Adverse reactionsExact identifier
rxcui: 797544
DepressoforcePICRICUM ACIDUM, ARSENICUM ALBUM, AURUM METALLICUM, IGNATIA AMARA, NATRUM MURIATICUM, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.e6b98979-a38c-4f13-af03-f5ffa962b4fa2026-03-27WarningsExact identifier
unii: 451W47IQ8X
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.077a9171-283d-47b6-bddc-34c739f6d69d2026-03-27WarningsExact identifier
unii: 451W47IQ8X
Swim-EARSWIM-EARFougera Pharmaceuticals, LLCb849acb5-e20b-464c-948b-8dcc51fdaf702026-03-26WarningsExact identifier
unii: ND2M416302
Buffer pHCHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIANaturalCare2161a2e2-613d-4dac-a5f6-796d40e849d92026-03-25WarningsExact identifier
unii: 451W47IQ8X
THESIS PHARMACY Alcohol Prep PadISOPROPYL ALCOHOLCarelife (USA) Inc.841d8b55-6383-4e02-9047-7b01e9f20a542026-03-24WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Reflux AwayABIES NIGRA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLOCYNTHIS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICANaturalCare8a00a72f-60df-4477-b7b8-abb6355e34da2026-03-24WarningsExact identifier
unii: 451W47IQ8X
Worafy Gentle Eye WashSODIUM CHLORIDEShenzhen Shandian Jingling Technology Co., Ltd.4da864dc-e10c-1db9-e063-6394a90a09842026-03-22WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDE HYPERTONICITYSODIUM CHLORIDEYYBA CORP439653b9-99b8-4799-8d67-4a2ada9c67832026-03-20WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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