FDA.reportPublic FDA data

LEVETIRACETAM

Substance profile for UNII 44YRR34555, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for LEVETIRACETAM
Structure render from PubChem CID 5284583

Substance Identity#

UNII
44YRR34555
Preferred term
LEVETIRACETAM
Registry number
102767-28-2
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C8H14N2O2
Chemical structure for LEVETIRACETAM
Structure render from PubChem CID 5284583

Chemical And Database Identifiers#

InChIKey
HPHUVLMMVZITSG-LURJTMIESA-N
SMILES
CC[C@H](N1CCCC1=O)C(N)=O
RxCUI
114477
PubChem
5284583
NCIt
C47581
INN ID
6450

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound5284583pubchem.ncbi.nlm.nih.gov/compound/5284583
PubChem InChIKey SearchHPHUVLMMVZITSG-LURJTMIESA-Npubchem.ncbi.nlm.nih.gov/#query=HPHUVLMMVZITSG-LURJTMIESA-N
RxNorm114477mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=114477
NCI ThesaurusC47581ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C47581
FDA Substance Registration System44YRR34555precision.fda.gov/uniisearch/srs/unii/44YRR34555

DailyMed Socrata Ingredients#

Type, DailyMed label, SPL version table
TypeDailyMed labelSPL version
ACTIVE INGREDIENTLEVETIRACETAM3
ACTIVE MOIETYLEVETIRACETAM3
ACTIVE INGREDIENTThese highlights do not include all the information needed to use levetiracetam tablets safely and effectively. See full prescribing information for levetiracetam tablets. Levetiracetam Tablets, USP for oral use Initial U.S. Approval: 199916
ACTIVE MOIETYThese highlights do not include all the information needed to use levetiracetam tablets safely and effectively. See full prescribing information for levetiracetam tablets. Levetiracetam Tablets, USP for oral use Initial U.S. Approval: 199916
ACTIVE INGREDIENTThese highlights do not include all the information needed to use levetiracetam tablets safely and effectively. See full prescribing information for levetiracetam tablets. LEVETIRACETAM tablets, USP for oral use Initial U.S. Approval: 19995
ACTIVE MOIETYThese highlights do not include all the information needed to use levetiracetam tablets safely and effectively. See full prescribing information for levetiracetam tablets. LEVETIRACETAM tablets, USP for oral use Initial U.S. Approval: 19995
ACTIVE MOIETYThese highlights do not include all the information needed to use levetiracetam tablets safely and effectively. See full prescribing information for levetiracetam tablets USP. Levetiracetam Tablets USP for Oral Use Initial U.S. Approval: 19992
ACTIVE INGREDIENTThese highlights do not include all the information needed to use levetiracetam tablets safely and effectively. See full prescribing information for levetiracetam tablets USP. Levetiracetam Tablets USP for Oral Use Initial U.S. Approval: 19992
ACTIVE INGREDIENTThese highlights do not include all the information needed to use levetiracetam extended-release tablets safely and effectively. See full prescribing information for levetiracetam extended-release tablets. Levetiracetam extended-release tablets Initial U.S. Approval: 19993
ACTIVE MOIETYThese highlights do not include all the information needed to use levetiracetam extended-release tablets safely and effectively. See full prescribing information for levetiracetam extended-release tablets. Levetiracetam extended-release tablets Initial U.S. Approval: 19993
ACTIVE INGREDIENTThese highlights do not include all the information needed to use levetiracetam tablets safely and effectively. See full prescribing information for levetiracetam tablets. LEVETIRACETAM Tablets USP, for oral use Initial U.S. Approval: 19992
ACTIVE MOIETYThese highlights do not include all the information needed to use levetiracetam tablets safely and effectively. See full prescribing information for levetiracetam tablets. LEVETIRACETAM Tablets USP, for oral use Initial U.S. Approval: 19992
ACTIVE MOIETYThese highlights do not include all the information needed to use Levetiracetam Oral Solution, USP safely and effectively. See full prescribing information for Levetiracetam Oral Solution, USP. Levetiracetam Oral Solution, USP Initial U.S. Approval: 19999
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Levetiracetam Oral Solution, USP safely and effectively. See full prescribing information for Levetiracetam Oral Solution, USP. Levetiracetam Oral Solution, USP Initial U.S. Approval: 19999
ACTIVE MOIETYLevetiracetam Tablets 500 mg1
ACTIVE INGREDIENTLevetiracetam Tablets 500 mg1
ACTIVE MOIETYLevetiracetam Oral Solution 100 mg/mL3
ACTIVE INGREDIENTLevetiracetam Oral Solution 100 mg/mL3
ACTIVE INGREDIENTThese highlights do not include all the information needed to use levetiracetam tablets safely and effectively. See full prescribing information for levetiracetam tablets. Levetiracetam Tablets USP, for oral use Initial U.S. Approval: 19991
ACTIVE MOIETYThese highlights do not include all the information needed to use levetiracetam tablets safely and effectively. See full prescribing information for levetiracetam tablets. Levetiracetam Tablets USP, for oral use Initial U.S. Approval: 19991
ACTIVE MOIETYe59f2fec-52d2-428f-a43a-c1d6c0f83f331
ACTIVE INGREDIENTe59f2fec-52d2-428f-a43a-c1d6c0f83f331
ACTIVE MOIETYLevetiracetam Tablets Rx Only1
ACTIVE INGREDIENTLevetiracetam Tablets Rx Only1
ACTIVE INGREDIENTThese highlights do not include all the information needed to use levetiracetam tablets safely and effectively. See full prescribing information for levetiracetam tablets USP. Levetiracetam Tablets USP for Oral Use Initial U.S. Approval: 19991
ACTIVE MOIETYThese highlights do not include all the information needed to use levetiracetam tablets safely and effectively. See full prescribing information for levetiracetam tablets USP. Levetiracetam Tablets USP for Oral Use Initial U.S. Approval: 19991
ACTIVE MOIETYLevetiracetam Tablets Rx Only Revised: March, 20113
ACTIVE INGREDIENTLevetiracetam Tablets Rx Only Revised: March, 20113
ACTIVE MOIETYThese highlights do not include all the information needed to use Levetiracetam Oral Solution, USP safely and effectively. See full prescribing information for Levetiracetam Oral Solution, USP. Levetiracetam Oral Solution, USP Initial U.S. Approval: 19994
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Levetiracetam Oral Solution, USP safely and effectively. See full prescribing information for Levetiracetam Oral Solution, USP. Levetiracetam Oral Solution, USP Initial U.S. Approval: 19994
ACTIVE MOIETYLevetiracetam Tablets 500 mg1
ACTIVE INGREDIENTLevetiracetam Tablets 500 mg1
ACTIVE MOIETYLevetiracetam Tablets 250 mg, 500 mg and 750 mg1
ACTIVE INGREDIENTLevetiracetam Tablets 250 mg, 500 mg and 750 mg1
ACTIVE INGREDIENT4aad770b-a342-45c5-8199-21a1240603141
ACTIVE MOIETY4aad770b-a342-45c5-8199-21a1240603141
ACTIVE MOIETYThese highlights do not include all the information needed to use KEPPRA ® safely and effectively. See full prescribing information for KEPPRA. KEPPRA (levetiracetam) tablets, for oral use KEPPRA (levetiracetam) oral solution Initial U.S. Approval: 19993
ACTIVE INGREDIENTThese highlights do not include all the information needed to use KEPPRA ® safely and effectively. See full prescribing information for KEPPRA. KEPPRA (levetiracetam) tablets, for oral use KEPPRA (levetiracetam) oral solution Initial U.S. Approval: 19993
ACTIVE INGREDIENTThese 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 100 mg/mL Oral Solution Initial U.S. Approval: 19992
ACTIVE MOIETYThese 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 100 mg/mL Oral Solution Initial U.S. Approval: 19992
ACTIVE MOIETYThese highlights do not include all the information needed to use levetiracetam safely and effectively. See full prescribing information for levetiracetam. Levetiracetam Tablets, USP Initial U.S. Approval: 19997
ACTIVE INGREDIENTThese highlights do not include all the information needed to use levetiracetam safely and effectively. See full prescribing information for levetiracetam. Levetiracetam Tablets, USP Initial U.S. Approval: 19997
ACTIVE MOIETYLevetiracetam Tablets, USP1
ACTIVE INGREDIENTLevetiracetam Tablets, USP1
ACTIVE MOIETYLevetiracetam1
ACTIVE INGREDIENTLevetiracetam1
ACTIVE INGREDIENTThese highlights do not include all the information needed to use levetiracetam extended-release tablets safely and effectively. See full prescribing information for levetiracetam extended-release tablets. LEVETIRACETAM extended-release tablets for oral use Initial U.S. Approval: 19991
ACTIVE MOIETYThese highlights do not include all the information needed to use levetiracetam extended-release tablets safely and effectively. See full prescribing information for levetiracetam extended-release tablets. LEVETIRACETAM extended-release tablets for oral use Initial U.S. Approval: 19991
ACTIVE INGREDIENT6d71e14f-8092-444c-afa1-2b79d69d81e63
ACTIVE MOIETY6d71e14f-8092-444c-afa1-2b79d69d81e63
ACTIVE MOIETYThese highlights do not include all the information needed to use LEVETIRACETAM safely and effectively. See full prescribing information for LEVETIRACETAM. Levetiracetam Injection for intravenous use. Initial U.S. Approval : 19992
ACTIVE INGREDIENTThese highlights do not include all the information needed to use LEVETIRACETAM safely and effectively. See full prescribing information for LEVETIRACETAM. Levetiracetam Injection for intravenous use. Initial U.S. Approval : 19992
ACTIVE MOIETY7b1d9124-5fde-4f57-9fca-ee061750fcc31
ACTIVE INGREDIENT7b1d9124-5fde-4f57-9fca-ee061750fcc31
ACTIVE INGREDIENTLevetiracetam Tablets1
ACTIVE MOIETYLevetiracetam Tablets1
ACTIVE MOIETYKEPPRA ® (levetiracetam) 250 mg, 500 mg, 750 mg, and 1000 mg tablets 100 mg/mL oral solution1
ACTIVE INGREDIENTKEPPRA ® (levetiracetam) 250 mg, 500 mg, 750 mg, and 1000 mg tablets 100 mg/mL oral solution1
ACTIVE INGREDIENTLevetiracetam Tablets 1000 mg1
ACTIVE MOIETYLevetiracetam Tablets 1000 mg1
ACTIVE MOIETYLevetiracetam1
ACTIVE INGREDIENTLevetiracetam1
ACTIVE INGREDIENTLevetiracetam Tablets1
ACTIVE MOIETYLevetiracetam Tablets1
ACTIVE MOIETYLevetiracetam Tablets1
ACTIVE INGREDIENTLevetiracetam Tablets1
ACTIVE MOIETY97d9d2b7-745b-413e-a7ba-8ebe207a463f1
ACTIVE INGREDIENT97d9d2b7-745b-413e-a7ba-8ebe207a463f1
ACTIVE INGREDIENTLEVETIRACETAM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3504
ACTIVE MOIETYLEVETIRACETAM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3504
ACTIVE INGREDIENTLEVETIRACETAM TABLET, FILM COATED [LAKE EIRE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3154
ACTIVE MOIETYLEVETIRACETAM TABLET, FILM COATED [LAKE EIRE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3154
ACTIVE MOIETYLEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
ACTIVE INGREDIENTLEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
ACTIVE INGREDIENTLEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYLEVETIRACETAM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTLEVETIRACETAM (LEVETIRACETAM) TABLET [REMEDYREPACK INC. ]74
ACTIVE MOIETYLEVETIRACETAM (LEVETIRACETAM) TABLET [REMEDYREPACK INC. ]74
ACTIVE INGREDIENTLEVETIRACETAM SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]23
ACTIVE MOIETYLEVETIRACETAM SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]23
ACTIVE INGREDIENTLEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
ACTIVE MOIETYLEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
ACTIVE MOIETYLEVETIRACETAM SOLUTION [SILARX PHARMACEUTICALS, INC]18
ACTIVE INGREDIENTLEVETIRACETAM SOLUTION [SILARX PHARMACEUTICALS, INC]18
ACTIVE MOIETYLEVETIRACETAM SOLUTION [QUALITEST PHARMACEUTICALS]17
ACTIVE INGREDIENTLEVETIRACETAM SOLUTION [QUALITEST PHARMACEUTICALS]17
ACTIVE MOIETYKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
ACTIVE INGREDIENTKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
ACTIVE MOIETYLEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
ACTIVE INGREDIENTLEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
ACTIVE MOIETYLEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
ACTIVE INGREDIENTLEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
ACTIVE INGREDIENTKEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]14
ACTIVE MOIETYKEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.]14
ACTIVE MOIETYLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
ACTIVE INGREDIENTLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
ACTIVE INGREDIENTLEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
ACTIVE MOIETYLEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
ACTIVE INGREDIENTLEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC]12
ACTIVE MOIETYLEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC]12
ACTIVE MOIETYLEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
ACTIVE INGREDIENTLEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
ACTIVE INGREDIENTLEVETIRACETAM SOLUTION [HI-TECH PHARMACAL CO., INC.]11
ACTIVE MOIETYLEVETIRACETAM SOLUTION [HI-TECH PHARMACAL CO., INC.]11
ACTIVE INGREDIENTLEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
ACTIVE MOIETYLEVETIRACETAM TABLET, FILM COATED [PRINSTON PHARMACEUTICAL INC.]11
ACTIVE MOIETYLEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
ACTIVE INGREDIENTLEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
ACTIVE MOIETYLEVETIRACETAM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
ACTIVE INGREDIENTLEVETIRACETAM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]11
ACTIVE INGREDIENTLEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.]10
ACTIVE MOIETYLEVETIRACETAM TABLET [PD-RX PHARMACEUTICALS, INC.]10
ACTIVE MOIETYLEVETIRACETAM TABLET, FILM COATED [BOCA PHARMACAL, LLC]10
ACTIVE INGREDIENTLEVETIRACETAM TABLET, FILM COATED [BOCA PHARMACAL, LLC]10
ACTIVE INGREDIENTKEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.]9
ACTIVE MOIETYKEPPRA (LEVETIRACETAM) INJECTION, SOLUTION, CONCENTRATE [UCB, INC.]9
ACTIVE INGREDIENTLEVETIRACETAM TABLET, FILM COATED [AVPAK]9
ACTIVE MOIETYLEVETIRACETAM TABLET, FILM COATED [AVPAK]9
ACTIVE INGREDIENTLEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH]9
ACTIVE MOIETYLEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH]9