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 54 of 60 · 1,195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levetiracetam ERLEVETIRACETAMProficient Rx LP57b9dccb-6ee6-4e89-ab26-4c478e2df2b52022-04-01Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.24a08a93-df23-474b-873e-c59ec8855f9f2022-03-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Wild Horse 777 Moisturizing NasalSODIUM CHLORIDEWild Horse 777, Inc.b0b4dadd-11fa-3dbb-e053-2995a90a20972022-03-14WarningsExact identifier
unii: 451W47IQ8X
LevetiracetamLEVETIRACETAMFresenius Kabi USA, LLCcc4a06f1-6509-4650-b20c-259a393537332022-02-28Warnings, Adverse reactionsExact identifier
rxcui: 647121
unii: 44YRR34555
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.cc14fafd-3dcd-4fc8-bdbd-6f355c3757682022-02-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC8b44bfd3-70a4-4b47-bc7b-590f63b8cc752022-02-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ACNE HPCARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINCNatural Creations, Inc.b2368ab6-e233-4473-99fa-86e1fbc2a8792022-02-14WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCf62481fd-fcdb-4be6-ac13-29c590e925c32022-02-10Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.e44c41ae-c9c8-4dd8-ba6c-cebb585378aa2022-01-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist WalgreensSODIUM CHLORIDEWALGREEN COMPANYd6b9d4fc-b758-be32-e053-2995a90a25232022-01-29WarningsExact identifier
unii: 451W47IQ8X
LevetiracetamLEVETIRACETAMFresenius Kabi USA, LLCcc41696c-9cf0-4410-bacc-09132ee805ce2022-01-24Warnings, Adverse reactionsExact identifier
rxcui: 647121
unii: 44YRR34555
Extra Strenght Saline Mist Rite AidSODIUM CHLORIDERITE AID CORPORATIONd5b30fb2-4052-4a0c-e053-2a95a90aacd52022-01-16WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist Rite AidSODIUM CHLORIDERITE AIDd583067e-1133-7d7d-e053-2a95a90a1e362022-01-13WarningsExact identifier
unii: 451W47IQ8X
SinuCleanse Sterile Saline MistSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC648da2bc-bc91-4295-9e46-d3055cdc24182022-01-08WarningsExact identifier
unii: 451W47IQ8X
SinuCleanse Nasal DripSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INCd5129a91-50e7-6b94-e053-2a95a90a2b302022-01-08WarningsExact identifier
unii: 451W47IQ8X
SinuCleanse Sterile Saline Mist Daily CareSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INCd5131ab2-8213-3659-e053-2a95a90ab2ab2022-01-08WarningsExact identifier
unii: 451W47IQ8X
LevetiracetamLEVETIRACETAM INJECTIONDr.Reddy's Laboratories Incbe8ec971-c4f1-3e53-77e1-8337d9d506eb2021-12-31Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAM INJECTIONDr.Reddy's Laboratories Inc0a9234b7-46b1-8e6c-a992-90f86cfb6e002021-12-31Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Headek NasalBELLADONNA, GLONOINUM, COFFEA, NATRUM CARB, NATRUM MUR.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics976b9c85-68c9-46a5-9012-53cb24683b032021-12-29WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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