FDA.reportPublic FDA data

NDC 17856-0574-2 - 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
17856-0574
Requested NDC
17856-0574-2
Package NDCs from labels
17856-0574-2, 17856-0574-1, 17856-0574-3
Manufacturer
Atlantic Biologicals Corp.
Effective date
2026-10-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levetiracetam Levetiracetam - Atlantic Biologicals Corp.Atlantic Biologicals Corp.2026-10-15HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-04-08LEVETIRACETAM ORAL SOLUTION These 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
2024-04-08LEVETIRACETAM ORAL SOLUTION These 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
2024-04-08LEVETIRACETAM ORAL SOLUTION These 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
2023-01-30LEVETIRACETAM ORAL SOLUTION These 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
2023-01-30LEVETIRACETAM ORAL SOLUTION These 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
2023-01-30LEVETIRACETAM ORAL SOLUTION These 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
2021-08-25LEVETIRACETAM ORAL SOLUTION These 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
2021-08-25LEVETIRACETAM ORAL SOLUTION These 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
2021-08-25LEVETIRACETAM ORAL SOLUTION These 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
2020-01-31LEVETIRACETAM ORAL SOLUTION These 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
2020-01-31LEVETIRACETAM ORAL SOLUTION These 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
2020-01-31LEVETIRACETAM ORAL SOLUTION These 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0574-1LevetiracetamLevetiracetam72 in 1 BOX, UNIT-DOSESOLUTION724
17856-0574-2LevetiracetamLevetiracetam5 mL in 1 CUP, UNIT-DOSESOLUTION54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0574LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [ATLANTIC BIOLOGICALS CORP.]4Current NDC, Legacy NDC, 2 package rows20250529_56fed03f-38c3-4273-8fd7-522bc508bf36.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0574-1ML - Milliliter17856-05741ed00a3a-8998-4cdf-b218-a734586b1d9012020-02-13

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 20 of 34 · 672 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMCivica, Inc.1591c690-f4ed-44b7-a9d0-bff1fbb4bfef2025-05-01Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.125ffbf4-681e-451c-a96d-0b64166194742025-04-29WarningsExact identifier
unii: PDC6A3C0OX
TricitratesTRICITRATESChartwell RX, LLC2a80ea6b-6334-4c33-a35e-a5cb2939fbcb2025-04-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDKesin Pharma Corporation3140f8fe-0644-7561-e063-6394a90a2c282025-04-21Adverse reactionsExact identifier
unii: 1Q73Q2JULR
LevetiracetamLEVETIRACETAMMylan Pharmaceuticals Inc.0a987d59-560f-4650-96ec-31aec81953b52025-04-12Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell RX, LLC978a5a9d-f0ca-4308-a84b-3b132263bbb82025-04-09Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
LEVETIRACETAMLEVETIRACETAMQUAGEN PHARMACEUTICALS LLC1d67cb3c-1173-4dce-a79b-a3c36934ab2e2025-04-03Warnings, Adverse reactionsExact identifier
rxcui: 403884
unii: 44YRR34555
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
LevetiracetamLEVETIRACETAMHikma Pharmaceuticals USA Inc.8d767545-1eb9-45a5-bd16-e8a66e628fea2025-04-01Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Alka-Seltzer Heartburn Relief Lemon LimeANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCcc21af24-9a5b-6831-e053-2a95a90a0af42025-04-01WarningsExact identifier
unii: 2968PHW8QP
LEVETIRACETAMLEVETIRACETAMSolco Healthcare US, LLCcfe618ae-f7de-43d8-a754-3ce0a08c48ee2025-03-26Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMPreferred Pharmaceuticals Inc.8c16bc7b-672c-420a-a457-3500605333752025-03-20Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMA-S Medication Solutionsc82313cb-744f-45ef-b74c-1bdd055b21932025-03-18Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Alka-Seltzer Heartburn Relief Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCdc1641f8-54c2-0d86-e053-2995a90a1dce2025-03-11WarningsExact identifier
unii: 2968PHW8QP
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: 1Q73Q2JULR
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
unii: PDC6A3C0OX
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
unii: PDC6A3C0OX
LEVETIRACETAMLEVETIRACETAMKesin Pharma Corporation30a4626d-74f3-6385-e063-6394a90a29502025-03-01Warnings, Adverse reactionsExact identifier
rxcui: 403884
unii: 44YRR34555
LevetiracetamLEVETIRACETAMPD-Rx Pharmaceuticals, Inc.c2177034-e164-453c-be02-1cf91ce27a072025-02-28Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Clear Eyes Maximum Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINPrestige Brands Holdings, Inc.c3b0e344-68dd-4c35-bf46-744e612a5b152025-02-28WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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