FDA.reportPublic FDA data

NDC 0143-9282-01 - 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
0143-9282
Requested NDC
0143-9282-01
Package NDCs from labels
0143-9282-01, 0143-9282-10
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
0143-9282-01Levetiracetam in Sodium Chloride100 mL in 1 BAGINJECTION1003
0143-9282-10Levetiracetam in Sodium Chloride10 in 1 BOXINJECTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9282LEVETIRACETAM 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
0143-9282-01ML - Milliliter0143-9282c57758e1-e72a-45c3-a351-53654b28401712025-10-14
0143-9282-10ML - Milliliter0143-92829ba3d1f8-a8e2-43d4-85bd-44b98b8362be12025-10-14

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 45 of 63 · 1,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineffect eye dropsALUMINA SILICATA, CALCAREA FLUORICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, NATRUM MURIATICUM, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltde2259f58-3043-4af3-918d-d4403757aa1f2024-04-26WarningsExact identifier
unii: 451W47IQ8X
HPYL PLUSANGELICA ARCHANGELICA, GERANIUM MACULATUM, HYDRASTIS CANADENSIS, SINAPIS NIGRA, SYMPHYTUM OFFICINALE, RATANHIA, ACETICUM ACIDUM, CARBOLICUM ACIDUM, ORNITHOGALUM UMBELLATUM, ABIES CANADENSIS, ANACARDIUM ORIENTALE, BISMUTHUM SUBNITRICUM, CONDURANGO, GRAPHITES, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, MEZEREUM, EUPHORBIUM OFFICINARUM, NUX VOMICA, URANIUM NITRICUMDeseret Biologicals, Inc.39445c53-e661-4203-a4fb-a071075ac0e22024-04-26WarningsExact identifier
unii: Q40Q9N063P
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEFresenius Kabi USA, LLC7a723a23-3bc1-4f69-b82f-d06a35dc68d62024-04-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCc1e52670-c85e-4f19-a2e9-bf9abd7c37272024-04-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LevetiracetamLEVETIRACETAMB. Braun Medical Inc.ad32ec2f-b4e0-4811-8ea1-7a4abdd5c0a62024-04-23Warnings, Adverse reactionsExact identifier
rxcui: 1193358
rxcui: 1193362
rxcui: 1193360
unii: 44YRR34555
GlyregACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCADeseret Biologicals, Inc28e670ca-ed35-4256-af20-74c25dc180992024-04-23WarningsExact identifier
unii: Q40Q9N063P
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
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): 00143928201
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
Dextrose And Sodium ChlorideDEXTROSE AND SODIUM CHLORIDEB. Braun Medical Inc.8e6569ce-9714-497f-a94b-c6975c1d76f62024-04-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
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

Reported adverse events (FAERS/openFDA)#

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