FDA.reportPublic FDA data

NDC 0143-9673-01 - 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
0143-9673
Requested NDC
0143-9673-01
Package NDCs from labels
0143-9673-01, 0143-9673-10, 0143-9673-25
Manufacturer
Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A
Effective date
2025-04-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levetiracetam - Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.AHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A2025-04-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9673-01Levetiracetam5 mL in 1 VIAL, GLASSINJECTION515
0143-9673-10Levetiracetam10 in 1 BOXINJECTION1015
0143-9673-25Levetiracetam25 in 1 CARTONINJECTION2515

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9673LEVETIRACETAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]14Current NDC, Legacy NDC, 3 package rows20240418_8d767545-1eb9-45a5-bd16-e8a66e628fea.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9673-01ML - Milliliter0143-9673cc20547c-68fe-4328-87d7-2653461b1dc512015-11-12
0143-9673-10ML - Milliliter0143-96738f97d1ce-cce7-4793-93b8-f7e0cbc4b0f412012-07-24
0143-9673-25ML - Milliliter0143-96731453913d-19bb-44e9-a450-4e540b38b39212016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]4
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]4
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PLEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]4
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BLEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]4
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM INJECTION [WEST-WARD PHARMACEUTICALS CORP]4

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 63 · 1,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Isolyte P in DextroseDEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASICB. Braun Medical Inc.4ea4397c-2fa4-4670-91e6-21ae498c88f72024-06-24Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Sodium ChlorideSODIUM CHLORIDECODAN US CORPORATIONaa06e286-75c6-4d7a-959f-6008d38aa6e52024-06-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LevetiracetamLEVETIRACETAMAmerican Health Packaging031a32e1-675a-4efe-a66b-40beb4fe51012024-06-21Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Derma Pain PlusCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOXICODENDRON, SARSAPARILLA (SMILAX REGELII)Peaceful Mountain, Inc.6fa79c31-e48e-4c83-baa2-96cef22cfee12024-06-13WarningsExact identifier
unii: 451W47IQ8X
Cold Sore RescueBORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEAPeaceful Mountain, Inc.a7fe6ec7-a758-43cf-b46f-c327e0632fb82024-06-13WarningsExact identifier
unii: 451W47IQ8X
LevetiracetamLEVETIRACETAMAmneal Pharmaceuticals LLC5c4877cc-52bc-4f98-a995-0aa9439da7422024-06-11Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Levetiracetam ERLEVETIRACETAMWestminster Pharmaceuticals, LLCc508a392-0603-477d-8a45-3ec5503711112024-06-10Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
NATRUM MURNATRUM MURRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a22655a-68f3-4f13-e063-6294a90ae52c2024-06-05WarningsExact identifier
unii: 451W47IQ8X
LEVETIRACETAMLEVETIRACETAMHospira, Inc.f1935bc8-30ce-4b51-8a4c-0f12ce9000a62024-06-05Warnings, Adverse reactionsExact identifier
rxcui: 647121
unii: 44YRR34555
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LevetiracetamLEVETIRACETAMBryant Ranch Prepackbc8b413f-2f07-4e6a-bb8e-a1f2119ae1cf2024-05-30Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMActavis Pharma, Inc.5cb4a1db-f32d-44af-8985-0a94ca5064682024-05-30Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMBryant Ranch Prepackadbcb0f7-0421-47e2-854e-e1cfefb6386f2024-05-29Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
levetiracetamLEVETIRACETAMMylan Institutional LLCe86dc508-4d22-493b-bdf1-408b6484d3f12024-05-28Warnings, Adverse reactionsExact identifier
rxcui: 647121
unii: 44YRR34555
Mentox HPAURUM METALLICUM, BARYTA CARBONICA, CALCAREA CARBONICA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.ebb23637-4931-4563-ab30-99bea02765802024-05-28WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLCdbed53b7-0109-4561-8342-0178ec8c64b02024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC1b912c7e-f005-4af4-b683-0834409642492024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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