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
Manufacturer
Atlantic Biologicals Corp.
Effective date
2026-07-27
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.2026-07-27HUMAN 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
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
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 2 of 35 · 682 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEVETIRACETAMLEVETIRACETAMMicro Labs Limited1e3cfafe-5784-4ec6-91dc-cd74b01d0bb42026-08-03Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
Levetiracetam LevetiracetamLEVETIRACETAMAtlantic Biologicals Corp.56fed03f-38c3-4273-8fd7-522bc508bf362026-07-27Warnings, Adverse reactionsExact identifier
application number: ANDA203052
ndc (package): 17856-0574-1
ndc (package): 17856-0574-2
ndc (product): 17856-0574
ndc11 (package): 17856057402
rxcui: 403884
spl id: 579e0b39-a063-e168-e063-6294a90aef60
spl set id: 56fed03f-38c3-4273-8fd7-522bc508bf36
unii: 44YRR34555
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LevetiracetamLEVETIRACETAMCardinal Health 107, LLCa91defd2-486b-4995-ba4c-640525ab575d2026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 403884
unii: 44YRR34555
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.dfc218c5-672a-420a-b59e-2e0b054e99ad2026-07-14Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.ae405796-1eca-4890-bcb2-e1b07654a24d2026-07-08Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
LEVETIRACETAMLEVETIRACETAMBryant Ranch Prepackace53552-d616-45e8-9f99-2f0041d0b4302026-07-06Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMCoupler LLC266d4ead-fda2-f030-e063-6394a90a68e22026-07-06Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.1c26c0ad-9d37-45c5-9091-849509f4fc012026-07-02Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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