FDA.reportPublic FDA data

NDC 59746-591-01 - levetiracetam

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
59746-591
Requested NDC
59746-591-01
Package NDCs from labels
59746-591-01, 59746-591-10, 59746-591-23
Manufacturer
Jubilant Cadista Pharmaceuticals Inc. | Jubilant Generics Limited | Jubilant HollisterStier LLC
Effective date
2021-01-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levetiracetam Injection - Jubilant Cadista Pharmaceuticals Inc. | Jubilant Generics Limited | Jubilant HollisterStier LLCJubilant Cadista Pharmaceuticals Inc. | Jubilant Generics Limited | Jubilant HollisterStier LLC2021-01-13HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
59746-591-102026-01-05These highlights do not include all the information needed to use LEVETIRACETAM INJECTION safely and effectively. See full prescribing information for LEVETIRACETAM INJECTION. LEVETIRACETAM injection for intravenous use Initial U.S. Approval: 1999
59746-591-232026-01-05These highlights do not include all the information needed to use LEVETIRACETAM INJECTION safely and effectively. See full prescribing information for LEVETIRACETAM INJECTION. LEVETIRACETAM injection for intravenous use Initial U.S. Approval: 1999
59746-591-102023-01-30These highlights do not include all the information needed to use LEVETIRACETAM INJECTION safely and effectively. See full prescribing information for LEVETIRACETAM INJECTION. LEVETIRACETAM injection for intravenous use Initial U.S. Approval: 1999
59746-591-232023-01-30These highlights do not include all the information needed to use LEVETIRACETAM INJECTION safely and effectively. See full prescribing information for LEVETIRACETAM INJECTION. LEVETIRACETAM injection for intravenous use Initial U.S. Approval: 1999

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-591LEVETIRACETAM (LEVETIRACETAM INJECTION) INJECTION, SOLUTION, CONCENTRATE [JUBILANT CADISTA PHARMACEUTICALS INC.]6Legacy NDC20210115_0d7d109f-15fc-4d95-ef6a-0e82aa98b30c.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 7 of 63 · 1,252 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PlegisolPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEHospira, Inc.35a174f0-f0d7-4ec7-3f81-d3d572c059cf2026-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsExact identifier
unii: 451W47IQ8X
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LevetiracetamLEVETIRACETAMPreferred Pharmaceuticals, Inc.419b3dba-ae21-4268-ac8b-342aaa6095542026-05-18Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMBryant Ranch Prepackc4a3018a-3cd8-4e07-a840-099ceae01c912026-05-15Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
LevetiracetamLEVETIRACETAMCoupler LLC51b66893-f7d6-8f9d-e063-6294a90a8e9b2026-05-13Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMLupin Pharmaceuticals, Inc.df661166-325d-4071-9bc1-f7bf992996d22026-05-11Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 451W47IQ8X
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 451W47IQ8X
LevetiracetamLEVETIRACETAMASCLEMED USA INC.a3c57d82-511c-4c7d-84ff-f791f931f5762026-05-07Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMCoupler LLC513f422f-1637-5f41-e063-6294a90ab5482026-05-07Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LevetiracetamLEVETIRACETAMBryant Ranch Prepack65a76fcb-31a8-4c5a-9ffe-5393fc4dac342026-05-06Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: Q40Q9N063P
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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