FDA.reportPublic FDA data

NDC 66689-028-01 - 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
66689-028
Requested NDC
66689-028-01
Package NDCs from labels
66689-028-01, 66689-028-50
Manufacturer
VistaPharm, LLC
Effective date
2022-11-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levetiracetam - VistaPharm, LLCVistaPharm, LLC2022-11-30HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-028-01ML - Milliliter66689-02854873b8a-90c5-453e-bc14-4ce23bc212d212012-07-24
66689-028-50ML - Milliliter66689-028a8c7728e-1bbd-4637-9c28-3865ce4ee85e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LevetiracetamACTIVE INGREDIENT44YRR34555LEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
LevetiracetamACTIVE MOIETY44YRR34555LEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G9LEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
glycyrrhizin, ammoniatedINACTIVE INGREDIENT3VRD35U26CLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
maltitolINACTIVE INGREDIENTD65DG142WKLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
waterINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2

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 28 of 36 · 709 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
PREPARATION H Maximum StrengthGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLHaleon US Holdings LLC7cc03d2e-e708-589a-d9bb-58ebbda989c02024-04-05WarningsExact identifier
unii: PDC6A3C0OX
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
ANTICOAGULANT SODIUM CITRATETRISODIUM CITRATE DIHYDRATEBaxter Healthcare Corporation7025a0f9-1a56-4416-a3a4-925d755aed902024-04-02Exact identifier
unii: B22547B95K
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
rxcui: 403884
unii: 44YRR34555
ELEPSIA XR 1000 MGLEVETIRACETAMTRIPOINT THERAPEUTICS, LLCcac83d47-88a2-4447-a0c0-90b44ffda0ac2024-03-25Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMGland Pharma Limitedaa883d9c-c6cd-44ab-a1de-058985e4f97f2024-03-25Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
LevetiracetamLEVETIRACETAMMylan Institutional LLC70e52e89-3844-4cd9-a406-b29e9520a12c2024-03-15Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMProficient Rx LP6bdbc193-d86b-4bd5-8e88-4ea964d2cdde2024-03-01Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC699310e8-1a93-40b4-a8f4-a765be4a0cb12024-02-29WarningsExact identifier
unii: PDC6A3C0OX
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
LevetiracetamLEVETIRACETAMPatrin Pharma, Inc.49117cee-a96c-4593-91a7-8a133e3f09392024-02-15Warnings, Adverse reactionsExact identifier
rxcui: 403884
unii: 44YRR34555

Reported adverse events (FAERS/openFDA)#

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