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 12 of 89 · 1,774 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
70%ISOPROPYL ALCOHOLYour Military Exchanges3dcb8422-827d-479b-ba18-eee8dbb762e12026-04-30Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLPerrigo Direct, Inc11d89d11-103e-4ef6-a996-65cff67f9b322026-04-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLWalmart Inc.1fd3d29f-7da0-c5ba-e063-6294a90add162026-04-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
leuprolide acetateLEUPROLIDE ACETATESun Pharmaceutical Industries, Inc.a3b01473-30c7-4945-bd60-2484221aaaad2026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 797544
Leuprolide AcetateLEUPROLIDE ACETATEMeitheal Pharmaceuticals Incd6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa5842026-04-23Warnings, Adverse reactionsExact identifier
rxcui: 797544
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
unii: 451W47IQ8X
3M DuraPrep SurgicalIODINE POVACRYLEX AND ISOPROPYL ALCOHOLSolventum US LLC22a10a54-6a04-48b3-9ec4-b26526183daf2026-04-23WarningsExact identifier
unii: ND2M416302
3M SoluPrep SCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLSolventum US LLC084aa305-5863-441a-a94d-36bc1b05195a2026-04-23WarningsExact identifier
unii: ND2M416302
RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical, Inc.a926f913-18fa-4a3e-bfd6-210e1e4279602026-04-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Cardioforce IIABROTANUM, BOLDO, CIMICIFUGA RACEMOSA, KALI PHOSPHORICUM, TARAXACUM OFFICINALE, CONVALLARIA MAJALIS, MAGNESIA SULPHURICA, OLEANDER, NATRUM MURIATICUM, BELLIS PERENNISBioActive Nutritional, Inc.733bbb26-7698-4a1b-9dc8-7e3490ffc92b2026-04-17WarningsExact identifier
unii: 451W47IQ8X
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA, SPONGIA TOSTA, THYROIDINUM (SUIS)BioActive Nutritional, Inc.3795820a-cf2a-4094-9a02-70e3757b75102026-04-17WarningsExact identifier
unii: 451W47IQ8X
DIANEAL Low Calcium with DextroseSODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCaa268d3f-7389-4f25-801f-5d4825495f082026-04-16Warnings, Adverse reactionsExact identifier
unii: 02F3473H9O
unii: 451W47IQ8X
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.b251752d-7750-482a-9364-0acf4ad47cc82026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC99c6a1a9-cadf-435b-a332-ccc189afdfa92026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ALCOHOL PREP PADS LARGE STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO.,LTD4f8ba6c8-5155-c491-e063-6394a90adde92026-04-15WarningsExact identifier
rxcui: 797544
unii: ND2M416302
GoLYTELYPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.7609ecf7-0ce0-4fbb-9c27-30987f6895752026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Anxiety ReliefACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI CARBONICUM, MOSCHUS, NATRUM MURIATICUM, PIPER METHYSTICUMNaturalCare9f982e89-655c-49be-85d8-4099a02ed0212026-04-15WarningsExact identifier
unii: 451W47IQ8X
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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