FDA.reportPublic FDA data

NDC 0143-9283-01 - Levetiracetam in Sodium Chloride

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
0143-9283
Requested NDC
0143-9283-01
Package NDCs from labels
0143-9283-01, 0143-9283-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-04-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levetiracetam in Sodium Chloride - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2024-04-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9283-01Levetiracetam in Sodium Chloride100 mL in 1 BAGINJECTION1003
0143-9283-10Levetiracetam in Sodium Chloride10 in 1 BOXINJECTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9283LEVETIRACETAM IN SODIUM CHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, 2 package rows20250322_c723fd27-214c-45f6-b170-a3b807ffab07.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9283-01ML - Milliliter0143-92834559c32d-31e9-4d28-b027-294fe985aeda12025-10-14
0143-9283-10ML - Milliliter0143-9283d0bd2fb6-01da-413a-872e-ccf1f8c8f4dc12025-10-14

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 42 of 59 · 1,176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermaparEPIDERMIS (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PETROLEUM, RHUS TOX, SULPHUR, CAUSTICUMEnergique, Inc.f79fe29b-341e-4bee-9665-1805a7157d1a2024-04-22WarningsExact identifier
unii: 451W47IQ8X
levetiracetamLEVETIRACETAMSagent Pharmaceuticalsd2de9565-0c0b-4957-bafa-1a286103709e2024-04-18Warnings, Adverse reactionsExact identifier
rxcui: 1193358
rxcui: 1193362
rxcui: 1193360
unii: 44YRR34555
Levetiracetam in Sodium ChlorideLEVETIRACETAM IN SODIUM CHLORIDEHikma Pharmaceuticals USA Inc.c723fd27-214c-45f6-b170-a3b807ffab072024-04-12Warnings, Adverse reactionsExact identifier
application number: ANDA211356
ndc (package): 0143-9281-10
ndc (package): 0143-9281-01
ndc (package): 0143-9282-10
ndc (package): 0143-9283-10
ndc (package): 0143-9283-01
ndc (package): 0143-9282-01
ndc (product): 0143-9281
ndc (product): 0143-9282
ndc (product): 0143-9283
ndc11 (package): 00143928301
rxcui: 1193358
rxcui: 1193362
rxcui: 1193360
spl id: f3105bfa-50ba-4e2f-8eae-0313242d8dcf
spl set id: c723fd27-214c-45f6-b170-a3b807ffab07
unii: 44YRR34555
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEHikma Pharmaceuticals USA Inc.e5ee8caa-b6ca-45ba-98fb-8305e62821412024-04-10Adverse reactionsExact identifier
unii: 451W47IQ8X
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
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
rxcui: 1193358
rxcui: 1193362
rxcui: 1193360
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

Reported adverse events (FAERS/openFDA)#

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