FDA.reportPublic FDA data

IRBESARTAN

Substance profile for UNII J0E2756Z7N, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for IRBESARTAN
Structure render from PubChem CID 3749

Substance Identity#

UNII
J0E2756Z7N
Preferred term
IRBESARTAN
Registry number
138402-11-6
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C25H28N6O
Chemical structure for IRBESARTAN
Structure render from PubChem CID 3749

Chemical And Database Identifiers#

InChIKey
YOSHYTLCDANDAN-UHFFFAOYSA-N
SMILES
CCCCC1=NC2(CCCC2)C(=O)N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NN=NN5
RxCUI
83818
PubChem
3749
NCIt
C29130
INN ID
7229

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound3749pubchem.ncbi.nlm.nih.gov/compound/3749
PubChem InChIKey SearchYOSHYTLCDANDAN-UHFFFAOYSA-Npubchem.ncbi.nlm.nih.gov/#query=YOSHYTLCDANDAN-UHFFFAOYSA-N
RxNorm83818mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=83818
NCI ThesaurusC29130ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C29130
FDA Substance Registration SystemJ0E2756Z7Nprecision.fda.gov/uniisearch/srs/unii/J0E2756Z7N

DailyMed Socrata Ingredients#

Type, DailyMed label, SPL version table
TypeDailyMed labelSPL version
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide Tablets USP safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide Tablets USP. Irbesartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 19972
ACTIVE MOIETYThese highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide Tablets USP safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide Tablets USP. Irbesartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 19972
ACTIVE MOIETYIRBESARTAN TABLETS USP 7464 7465 75141002
ACTIVE INGREDIENTIRBESARTAN TABLETS USP 7464 7465 75141002
ACTIVE INGREDIENTIrbesartan Tablets USP Rx only10
ACTIVE MOIETYIrbesartan Tablets USP Rx only10
ACTIVE INGREDIENTThese highlights do not include all the information needed to use irbesartan and hydrochlorothiazide tablets USP safely and effectively. See full prescribing information for irbesartan and hydrochlorothiazide tablets USP. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets USP for oral use Initial U.S. Approval: 19974
ACTIVE MOIETYThese highlights do not include all the information needed to use irbesartan and hydrochlorothiazide tablets USP safely and effectively. See full prescribing information for irbesartan and hydrochlorothiazide tablets USP. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets USP for oral use Initial U.S. Approval: 19974
ACTIVE INGREDIENTAVAPRO ® (irbesartan) Tablets2
ACTIVE MOIETYAVAPRO ® (irbesartan) Tablets2
ACTIVE MOIETYThese highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE (irbesartan and hydrochlorothiazide) tablet for oral use AVALIDE (irbesartan and hydrochlorothiazide) tablet, film coated for oral use Initial U.S. Approval: 19972
ACTIVE INGREDIENTThese highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE (irbesartan and hydrochlorothiazide) tablet for oral use AVALIDE (irbesartan and hydrochlorothiazide) tablet, film coated for oral use Initial U.S. Approval: 19972
ACTIVE MOIETYAVAPRO (IRBESARTAN) TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3698
ACTIVE INGREDIENTAVAPRO (IRBESARTAN) TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3698
ACTIVE MOIETYAVAPRO (IRBESARTAN) TABLET [BRYANT RANCH PREPACK]1001
ACTIVE INGREDIENTAVAPRO (IRBESARTAN) TABLET [BRYANT RANCH PREPACK]1001
ACTIVE MOIETYAVAPRO (IRBESARTAN) TABLET [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTAVAPRO (IRBESARTAN) TABLET [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYIRBESARTAN (IRBESARTAN ) TABLET [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTIRBESARTAN (IRBESARTAN ) TABLET [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTAVAPRO (IRBESARTAN) TABLET [BRISTOL-MYERS SQUIBB COMPANY]9
ACTIVE MOIETYAVAPRO (IRBESARTAN) TABLET [BRISTOL-MYERS SQUIBB COMPANY]9
ACTIVE MOIETYIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]8
ACTIVE INGREDIENTIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]8
ACTIVE INGREDIENTIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [QUALITEST PHARMACEUTICALS]8
ACTIVE MOIETYIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [QUALITEST PHARMACEUTICALS]8
ACTIVE MOIETYIRBESARTAN TABLET [QUALITEST PHARMACEUTICALS]8
ACTIVE INGREDIENTIRBESARTAN TABLET [QUALITEST PHARMACEUTICALS]8
ACTIVE MOIETYIRBESARTAN TABLET, COATED [WATSON LABORATORIES, INC.]8
ACTIVE INGREDIENTIRBESARTAN TABLET, COATED [WATSON LABORATORIES, INC.]8
ACTIVE MOIETYIRBESARTAN (IRBESARTAN) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]7
ACTIVE INGREDIENTIRBESARTAN (IRBESARTAN) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]7
ACTIVE INGREDIENTIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
ACTIVE MOIETYIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6
ACTIVE MOIETYIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]6
ACTIVE INGREDIENTIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]6
ACTIVE INGREDIENTIRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]6
ACTIVE MOIETYIRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]6
ACTIVE INGREDIENTIRBESARTAN (IRBESARTAN ) TABLET IRBESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]5
ACTIVE MOIETYIRBESARTAN (IRBESARTAN ) TABLET IRBESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]5
ACTIVE INGREDIENTIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [APOTEX CORP.]5
ACTIVE MOIETYIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [APOTEX CORP.]5
ACTIVE MOIETYIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5
ACTIVE INGREDIENTIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5
ACTIVE MOIETYIRBESARTAN TABLET [LEGACY PHARMACEUTICAL PACKAGING]5
ACTIVE INGREDIENTIRBESARTAN TABLET [LEGACY PHARMACEUTICAL PACKAGING]5
ACTIVE INGREDIENTIRBESARTAN TABLET, FILM COATED [APOTEX CORP.]5
ACTIVE MOIETYIRBESARTAN TABLET, FILM COATED [APOTEX CORP.]5
ACTIVE INGREDIENTAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
ACTIVE MOIETYAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]4
ACTIVE INGREDIENTAVAPRO (IRBESARTAN) TABLET [SANOFI-AVENTIS U.S. LLC]4
ACTIVE MOIETYAVAPRO (IRBESARTAN) TABLET [SANOFI-AVENTIS U.S. LLC]4
ACTIVE INGREDIENTIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
ACTIVE MOIETYIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
ACTIVE MOIETYIRBESARTAN TABLET [TEVA PHARMACEUTICALS USA INC]4
ACTIVE INGREDIENTIRBESARTAN TABLET [TEVA PHARMACEUTICALS USA INC]4
ACTIVE MOIETYIRBESARTAN TABLET [CAMBER PHARMACEUTICALS, INC.]3
ACTIVE INGREDIENTIRBESARTAN TABLET [CAMBER PHARMACEUTICALS, INC.]3
ACTIVE MOIETYAVAPRO (IRBESARTAN) TABLET [CARDINAL HEALTH]2
ACTIVE INGREDIENTAVAPRO (IRBESARTAN) TABLET [CARDINAL HEALTH]2
ACTIVE MOIETYIRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
ACTIVE INGREDIENTIRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [AVKARE, INC.]2
ACTIVE MOIETYIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.]2
ACTIVE INGREDIENTIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.]2
ACTIVE MOIETYIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
ACTIVE INGREDIENTIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC ]2
ACTIVE INGREDIENTIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
ACTIVE MOIETYIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2
ACTIVE INGREDIENTIRBESARTAN TABLET [AMERICAN HEALTH PACKAGING]2
ACTIVE MOIETYIRBESARTAN TABLET [AMERICAN HEALTH PACKAGING]2
ACTIVE MOIETYIRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]2
ACTIVE INGREDIENTIRBESARTAN TABLET [AUROBINDO PHARMA LIMITED]2
ACTIVE MOIETYIRBESARTAN TABLET [CARILION MATERIALS MANAGEMENT]2
ACTIVE INGREDIENTIRBESARTAN TABLET [CARILION MATERIALS MANAGEMENT]2
ACTIVE INGREDIENTIRBESARTAN TABLET [ROXANE LABORATORIES, INC.]2
ACTIVE MOIETYIRBESARTAN TABLET [ROXANE LABORATORIES, INC.]2
ACTIVE MOIETYAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [CARDINAL HEALTH]1
ACTIVE INGREDIENTAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET [CARDINAL HEALTH]1
ACTIVE MOIETYAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [CARDINAL HEALTH]1
ACTIVE INGREDIENTAVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [CARDINAL HEALTH]1
ACTIVE INGREDIENTAVAPRO (IRBESARTAN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
ACTIVE MOIETYAVAPRO (IRBESARTAN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
ACTIVE MOIETYIRBESARTAN TABLET [AMERICAN HEALTH PACKAGING]1
ACTIVE INGREDIENTIRBESARTAN TABLET [AMERICAN HEALTH PACKAGING]1
ACTIVE MOIETYIRBESARTAN TABLET [AMERICAN HEALTH PACKAGING]1
ACTIVE INGREDIENTIRBESARTAN TABLET [AMERICAN HEALTH PACKAGING]1
ACTIVE MOIETYIRBESARTAN TABLET [AVPAK]1
ACTIVE INGREDIENTIRBESARTAN TABLET [AVPAK]1