FDA.reportPublic FDA data

TOPIRAMATE

Substance profile for UNII 0H73WJJ391, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for TOPIRAMATE
Structure render from PubChem CID 5284627

Substance Identity#

UNII
0H73WJJ391
Preferred term
TOPIRAMATE
Registry number
97240-79-4
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C12H21NO8S
Chemical structure for TOPIRAMATE
Structure render from PubChem CID 5284627

Chemical And Database Identifiers#

InChIKey
KJADKKWYZYXHBB-XBWDGYHZSA-N
SMILES
CC1(C)O[C@@H]2CO[C@@]3(COS(N)(=O)=O)OC(C)(C)O[C@H]3[C@@H]2O1
RxCUI
38404
PubChem
5284627
NCIt
C47764
INN ID
6099

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound5284627pubchem.ncbi.nlm.nih.gov/compound/5284627
PubChem InChIKey SearchKJADKKWYZYXHBB-XBWDGYHZSA-Npubchem.ncbi.nlm.nih.gov/#query=KJADKKWYZYXHBB-XBWDGYHZSA-N
RxNorm38404mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=38404
NCI ThesaurusC47764ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C47764
FDA Substance Registration System0H73WJJ391precision.fda.gov/uniisearch/srs/unii/0H73WJJ391

DailyMed Socrata Ingredients#

Type, DailyMed label, SPL version table
TypeDailyMed labelSPL version
ACTIVE MOIETYThese highlights do not include all the information needed to use topiramate tablets, USP safely and effectively. See full prescribing information for topiramate tablets, USPTopiramate Tablets, USP for oral use Initial U.S. Approval: 19965
ACTIVE INGREDIENTThese highlights do not include all the information needed to use topiramate tablets, USP safely and effectively. See full prescribing information for topiramate tablets, USPTopiramate Tablets, USP for oral use Initial U.S. Approval: 19965
ACTIVE MOIETYTOPIRAMATE1
ACTIVE INGREDIENTTOPIRAMATE1
ACTIVE MOIETYTOPIRAMATE6
ACTIVE INGREDIENTTOPIRAMATE6
ACTIVE MOIETYTOPIRAMATE5
ACTIVE INGREDIENTTOPIRAMATE5
ACTIVE INGREDIENTTOPIRAMATE- topiramate tablet1
ACTIVE MOIETYTOPIRAMATE- topiramate tablet1
ACTIVE INGREDIENTTOPIRAMATE1
ACTIVE MOIETYTOPIRAMATE1
ACTIVE INGREDIENTTopiramate2
ACTIVE MOIETYTopiramate2
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Topiramate Tablets USP safely and effectively. See full prescribing information for Topiramate Tablets USP. OPIRAMATE Tablets USP for oral use Initial U.S. Approval: 19961
ACTIVE MOIETYThese highlights do not include all the information needed to use Topiramate Tablets USP safely and effectively. See full prescribing information for Topiramate Tablets USP. OPIRAMATE Tablets USP for oral use Initial U.S. Approval: 19961
ACTIVE INGREDIENTThese highlights do not include all the information needed to use TOPIRAMATE Tablets safely and effectively. See full prescribing information for TOPIRAMATE Tablets. Initial U.S. Approval: 19965
ACTIVE MOIETYThese highlights do not include all the information needed to use TOPIRAMATE Tablets safely and effectively. See full prescribing information for TOPIRAMATE Tablets. Initial U.S. Approval: 19965
ACTIVE MOIETYTopiramate Tablets Rx Only3
ACTIVE INGREDIENTTopiramate Tablets Rx Only3
ACTIVE INGREDIENTThese highlights do not include all the information needed to use topiramate safely and effectively. See full prescribing information for topiramate. Initial U.S. Approval-19961
ACTIVE MOIETYThese highlights do not include all the information needed to use topiramate safely and effectively. See full prescribing information for topiramate. Initial U.S. Approval-19961
ACTIVE MOIETYTopiramate Tablets1
ACTIVE INGREDIENTTopiramate Tablets1
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Topiramate Tablets safely and effectively. See full prescribing information for Topiramate Tablets. TOPIRAMATE TABLETS USP for oral use Initial U.S. Approval: 19961
ACTIVE MOIETYThese highlights do not include all the information needed to use Topiramate Tablets safely and effectively. See full prescribing information for Topiramate Tablets. TOPIRAMATE TABLETS USP for oral use Initial U.S. Approval: 19961
ACTIVE MOIETYThese highlights do not include all the information needed to use Topiramate Tablets safely and effectively. See full prescribing information for Topiramate Tablets. TOPIRAMATE TABLETS USP for oral use Initial U.S. Approval: 19961
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Topiramate Tablets safely and effectively. See full prescribing information for Topiramate Tablets. TOPIRAMATE TABLETS USP for oral use Initial U.S. Approval: 19961
ACTIVE MOIETYTopiramate Tablets2
ACTIVE INGREDIENTTopiramate Tablets2
ACTIVE INGREDIENTTopiramate Tablets2
ACTIVE MOIETYTopiramate Tablets2
ACTIVE MOIETYThese highlights do not include all the information needed to use topiramate safely and effectively. See full prescribing information for topiramate. Topiramate Tablets, USP Topiramate Capsules (Sprinkle) "Initial U.S. Approval:". 199614
ACTIVE INGREDIENTThese highlights do not include all the information needed to use topiramate safely and effectively. See full prescribing information for topiramate. Topiramate Tablets, USP Topiramate Capsules (Sprinkle) "Initial U.S. Approval:". 199614
ACTIVE INGREDIENTTopiramate Tablets2
ACTIVE MOIETYTopiramate Tablets2
ACTIVE INGREDIENT011eedbd-efb1-4d4e-99f0-b6bca81fb5ad3
ACTIVE MOIETY011eedbd-efb1-4d4e-99f0-b6bca81fb5ad3
ACTIVE MOIETYThese highlights do not include all the information needed to use TOPAMAX ® safely and effectively. See full prescribing information for TOPAMAX ® TOPAMAX (topiramate) TABLETS for oral use TOPAMAX (topiramate capsules) SPRINKLE CAPSULES for oral use Initial U.S. Approval – 19962
ACTIVE INGREDIENTThese highlights do not include all the information needed to use TOPAMAX ® safely and effectively. See full prescribing information for TOPAMAX ® TOPAMAX (topiramate) TABLETS for oral use TOPAMAX (topiramate capsules) SPRINKLE CAPSULES for oral use Initial U.S. Approval – 19962
ACTIVE INGREDIENTTopiramate Tablets3
ACTIVE MOIETYTopiramate Tablets3
ACTIVE MOIETYThese highlights do not include all the information needed to use topiramate tablets safely and effectively. See full prescribing information for topiramate tablets Topiramate Tablets Rx Only Initial U.S. Approval - 19963
ACTIVE INGREDIENTThese highlights do not include all the information needed to use topiramate tablets safely and effectively. See full prescribing information for topiramate tablets Topiramate Tablets Rx Only Initial U.S. Approval - 19963
ACTIVE INGREDIENTThese highlights do not include all the information needed to use topiramate tablets safely and effectively. See full prescribing information for topiramate tablets Topiramate Tablets, USP Rx Only Initial U.S. Approval - 19963
ACTIVE MOIETYThese highlights do not include all the information needed to use topiramate tablets safely and effectively. See full prescribing information for topiramate tablets Topiramate Tablets, USP Rx Only Initial U.S. Approval - 19963
ACTIVE MOIETYTopiramate1
ACTIVE INGREDIENTTopiramate1
ACTIVE INGREDIENTThese highlights do not include all the information needed to use TOPAMAX ® safely and effectively. See full prescribing information for TOPAMAX ® TOPAMAX ® (topiramate) TABLETS Initial U.S. Approval: 19961
ACTIVE MOIETYThese highlights do not include all the information needed to use TOPAMAX ® safely and effectively. See full prescribing information for TOPAMAX ® TOPAMAX ® (topiramate) TABLETS Initial U.S. Approval: 19961
ACTIVE INGREDIENTTopiramate Tablets1
ACTIVE MOIETYTopiramate Tablets1
ACTIVE MOIETYTOPIRAMATE TABLETS Rx only1
ACTIVE INGREDIENTTOPIRAMATE TABLETS Rx only1
ACTIVE MOIETYTopiramate Tablets1
ACTIVE INGREDIENTTopiramate Tablets1
ACTIVE INGREDIENTTopiramate Tablets1
ACTIVE MOIETYTopiramate Tablets1
ACTIVE INGREDIENTTopiramate Tablets4
ACTIVE MOIETYTopiramate Tablets4
ACTIVE INGREDIENTTOPIRAMATE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3312
ACTIVE MOIETYTOPIRAMATE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3312
ACTIVE INGREDIENTTOPIRAMATE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3266
ACTIVE MOIETYTOPIRAMATE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3266
ACTIVE INGREDIENTTOPIRAMATE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2008
ACTIVE MOIETYTOPIRAMATE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2008
ACTIVE INGREDIENTTOPAMAX (TOPIRAMATE) TABLET, COATED [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYTOPAMAX (TOPIRAMATE) TABLET, COATED [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYTOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTTOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTTOPIRAMATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]15
ACTIVE MOIETYTOPIRAMATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]15
ACTIVE INGREDIENTTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
ACTIVE MOIETYTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
ACTIVE INGREDIENTTOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
ACTIVE MOIETYTOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
ACTIVE INGREDIENTTOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
ACTIVE MOIETYTOPIRAMATE CAPSULE, COATED PELLETS [TEVA PHARMACEUTICALS USA INC]14
ACTIVE INGREDIENTQSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
ACTIVE MOIETYQSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
ACTIVE INGREDIENTTOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]13
ACTIVE MOIETYTOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]13
ACTIVE INGREDIENTTOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
ACTIVE MOIETYTOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12
ACTIVE INGREDIENTTOPIRAMATE CAPSULE, COATED PELLETS [COBALT LABORATORIES]11
ACTIVE MOIETYTOPIRAMATE CAPSULE, COATED PELLETS [COBALT LABORATORIES]11
ACTIVE MOIETYTOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]11
ACTIVE INGREDIENTTOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]11
ACTIVE INGREDIENTTOPIRAMATE TABLET [TEVA PHARMACEUTICALS USA INC]11
ACTIVE MOIETYTOPIRAMATE TABLET [TEVA PHARMACEUTICALS USA INC]11
ACTIVE INGREDIENTTOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
ACTIVE MOIETYTOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
ACTIVE INGREDIENTTOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
ACTIVE MOIETYTOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
ACTIVE INGREDIENTTOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]11
ACTIVE MOIETYTOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]11
ACTIVE INGREDIENTTOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.]10
ACTIVE MOIETYTOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.]10
ACTIVE INGREDIENTTOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
ACTIVE MOIETYTOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
ACTIVE MOIETYTOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
ACTIVE INGREDIENTTOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
ACTIVE INGREDIENTTOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]7
ACTIVE MOIETYTOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]7
ACTIVE MOIETYQUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]6
ACTIVE INGREDIENTQUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]6
ACTIVE INGREDIENTTOPIRAMATE ( TOPIRAMATE ) TABLET [PD-RX PHARMACEUTICALS, INC.]6
ACTIVE INGREDIENTTOPIRAMATE ( TOPIRAMATE ) TABLET [PD-RX PHARMACEUTICALS, INC.]6
ACTIVE MOIETYTOPIRAMATE ( TOPIRAMATE ) TABLET [PD-RX PHARMACEUTICALS, INC.]6
ACTIVE MOIETYTOPIRAMATE ( TOPIRAMATE ) TABLET [PD-RX PHARMACEUTICALS, INC.]6
ACTIVE MOIETYTOPIRAMATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]6
ACTIVE INGREDIENTTOPIRAMATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]6
ACTIVE INGREDIENTTOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
ACTIVE MOIETYTOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
ACTIVE INGREDIENTTOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
ACTIVE MOIETYTOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
ACTIVE MOIETYTOPIRAMATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]5
ACTIVE INGREDIENTTOPIRAMATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]5
ACTIVE MOIETYTOPIRAMATE TABLET [CIPLA USA INC.]5
ACTIVE INGREDIENTTOPIRAMATE TABLET [CIPLA USA INC.]5