FDA.reportPublic FDA data

NDC 70518-3192-1 - Levetiracetam 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
70518-3192
Requested NDC
70518-3192-1
Package NDCs from labels
70518-3192-1, 70518-3192-0, 70518-3192-2, 70518-3192-3, 70518-3192-4, 70518-3192-5, 70518-3192-6
Manufacturer
REMEDYREPACK INC.
Effective date
2021-09-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levetiracetam Levetiracetam - REMEDYREPACK INC.REMEDYREPACK INC.2021-09-27HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70518-3192-02023-05-09These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
70518-3192-22023-05-09These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
70518-3192-32023-05-09These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
70518-3192-42023-05-09These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
70518-3192-52023-05-09These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
70518-3192-62023-05-09These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
70518-3192-02023-01-30These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
70518-3192-22023-01-30These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
70518-3192-32023-01-30These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
70518-3192-42023-01-30These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
70518-3192-52023-01-30These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
70518-3192-62023-01-30These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999

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 8 of 35 · 683 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
unii: PDC6A3C0OX
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX
LevetiracetamLEVETIRACETAMFresenius Kabi USA, LLCda858849-1d18-4d38-b53d-d4dd1cd8fabc2026-02-05Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMA-S Medication Solutions30f43d3b-c944-4f25-b5d3-0092949449622026-02-02Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
unii: PDC6A3C0OX
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
KeppraLEVETIRACETAMUCB, Inc.3ca9df05-a506-4ec8-a4fe-320f1219ab212026-01-28Warnings, Adverse reactionsExact identifier
rxcui: 403884
unii: 44YRR34555
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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