Irbesartan and Hydrochlorothiazide
These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide. Irbesartan and Hydrochlorothiazide tablets, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
4899b6d9-c080-4209-93fc-5b08394895e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2023
Manufacturers
FDA
Winthrop U.S, a business of sanofi-aventis U.S. LLC
DUNS: 824676584
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
irbesartan and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0955-1046
Application NumberNDA020758
Product Classification
M
Marketing Category
C73605
G
Generic Name
irbesartan and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2023
FDA Product Classification
INGREDIENTS (13)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
IRBESARTANActive
Quantity: 300 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
irbesartan and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0955-1045
Application NumberNDA020758
Product Classification
M
Marketing Category
C73605
G
Generic Name
irbesartan and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2023
FDA Product Classification
INGREDIENTS (13)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
IRBESARTANActive
Quantity: 150 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB