Irbesartan and Hydrochlorothiazide
These highlights do not include all the information needed to use IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS.IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
83f4acc1-697a-4770-b554-1b9a8fb5de74
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2021
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
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 Code0093-8238
Application NumberANDA077369
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2021
FDA Product Classification
INGREDIENTS (16)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
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
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Irbesartan and Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-8232
Application NumberANDA077369
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2021
FDA Product Classification
INGREDIENTS (16)
IRBESARTANActive
Quantity: 300 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT