FDA.reportPublic FDA data

NDC 0143-9574-01 - 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
0143-9574
Requested NDC
0143-9574-01
Package NDCs from labels
0143-9574-01, 0143-9574-10, 0143-9574-25
Manufacturer
Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A
Effective date
2025-05-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
WATER - Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.AHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A2025-05-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9574-01Levetiracetam5 mL in 1 VIAL, SINGLE-DOSEINJECTION512
0143-9574-10Levetiracetam10 in 1 CARTONINJECTION1012
0143-9574-25Levetiracetam25 in 1 CARTONINJECTION2512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9574LEVETIRACETAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 3 package rows20240920_097e5606-dd5e-4518-ab97-f71f68786444.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9574-01ML - Milliliter0143-9574a76b42f4-7d32-40c2-b6bf-cbd6e72f887012015-08-04
0143-9574-10ML - Milliliter0143-957414569afe-3337-4b39-a78b-89e0ee21517e12015-08-04
0143-9574-25ML - Milliliter0143-95746ab6fbc7-52bb-4c39-80f2-c82479ab8c5c12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]3
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]3
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PLEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]3
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BLEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]3
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]3

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 43 of 60 · 1,195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hers PlusCALENDULA OFFICINALIS, SAMBUCUS NIGRA, ALLIUM SATIVUM, CLEMATIS ERECTA, DULCAMARA, SARSAPARILLA (SMILAX REGELII), GRAPHITES, PETROLEUM, ARSENICUM ALBUM, CROTON TIGLIUM, MERCURIUS SULPHURATUS RUBER, NATRUM MURIATICUM, NITRICUM ACIDUM, RHUS TOX, SEPIA, THUJA OCCIDENTALISDeseret Biologicals,Inc.e4636b80-f6c8-459c-8d0e-ff7801358b102024-04-09WarningsExact identifier
unii: 451W47IQ8X
LevetiracetamLEVETIRACETAMAurobindo Pharma Limited2471ee03-d747-4113-86d0-1aa93c8f3eba2024-04-04Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMNovadoz Pharmaceuticals LLC484e8d8f-be40-46f8-a509-d1bbdbbd29812024-04-04Warnings, Adverse reactionsExact identifier
rxcui: 647121
unii: 44YRR34555
LevetiracetamLEVETIRACETAMBryant Ranch Prepacked8e88d0-993e-4683-bdcf-31578130d3df2024-04-03Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
SINU HCPLANTAGO MAJOR, PULSATILLA (PRATENSIS), LUFFA OPERCULATA, MERCURIUS IODATUS RUBER, MUCOSA NASALIS SUIS, EUPHORBIUM OFFICINARUM, ARGENTUM NITRICUM, HEPAR SULPHURIS CALCAREUM, CALCAREA CARBONICA, NATRUM MURIATICUM, SINUSITISINUMDeseret Biologicals, Inc.8b63e066-dd1b-4aee-a17b-4edc6b71a1cc2024-04-02WarningsExact identifier
unii: 451W47IQ8X
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
LevetiracetamLEVETIRACETAM IN SODIUM CHLORIDEEugia US LLCe5eb4c89-8ee9-4474-9cb1-c3b3dc262a4a2024-04-01Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LEVETIRACETAMLEVETIRACETAMSolco healthcare U.S., LLCbc8644ed-3320-47b5-adf3-8b972bea8abd2024-03-28Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMSolco Healthcare US, LLC57f09129-7151-4a75-9d73-9dd32f74ba432024-03-27Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMSolco Healthcare US, LLCdd713e60-478c-43cd-b680-ff594a0b38642024-03-27Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMPAI Holdings, LLC dba PAI Pharma9dca1330-52ca-47a4-a134-ec55c9d5786d2024-03-27Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy14931004-1efb-e331-e063-6294a90ad66e2024-03-26WarningsExact identifier
unii: 451W47IQ8X
Aqua marinaSODIUM CHLORIDEBoiron14945760-30b5-27d3-e063-6394a90a8a322024-03-26Exact identifier
unii: 451W47IQ8X
ACETIC ACIDACETIC ACIDChartwell RX, LLC2aaf3781-4f25-4799-8dcd-78d67e226ccc2024-03-26Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Headache HPBELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUMEnergique, Inc.5dca8670-c931-47e3-af89-b5f09f5f4e022024-03-26WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEB. Braun Medical Inc.59ccc717-c374-41c0-be58-9647df8811602024-03-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
V-Fem CareAGARICUS MUSC., ARSENICUM ALB., AUR. MET., BERBER. AQUI., CALADIUM SEGUINUM, CANDIDA ALBICANS, CANTHARIS, CONIUM, GRAPHITES, HELONIAS DIOICA, HYDRASTIS, KALI CARB., KREOSOTUM, LYCOPODIUM, MERC. VIV., MUREX PURPUREA, NAT. MUR., NITRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SEPIA, SULPHUR, TARENTULA HISPANA, THUJA OCC., ZINC. MET., APIS MEL., HAMAMELISNewton Laboratories, Inc.14800c19-e5c6-924b-e063-6394a90a15e52024-03-25WarningsExact identifier
unii: 451W47IQ8X
ControlANACARDIUM ORIENTALE, AQUA MARINA, ARGENTUM NITRICUM, ASARUM CANADENSE, BLATTA ORIENTALIS, BUFO RANA, CEREBRUM SUIS, CLEMATIS ERECTA, CUPRUM ACETICUM, HYPOTHALAMUS SUIS, IGNATIA AMARA, KALI PHOSPHORICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, PLACENTA TOTALIS SUIS, RHUS TOX, THUJA OCCIDENTALIS, THYMOLUM, VALERIANA OFFICINALISDeseret Biologicals, Inc.9daec04d-44fb-4d0f-8e21-1109f515eb5d2024-03-25WarningsExact identifier
unii: 451W47IQ8X
ELEPSIA XR 1000 MGLEVETIRACETAMTRIPOINT THERAPEUTICS, LLCcac83d47-88a2-4447-a0c0-90b44ffda0ac2024-03-25Warnings, Adverse reactionsExact identifier
unii: 44YRR34555

Reported adverse events (FAERS/openFDA)#

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