Irbesartan
These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
8c9bb449-6341-4f24-9d38-6ca952e07122
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 19, 2021
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Irbesartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-286
Application NumberANDA204740
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2021
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
IRBESARTANActive
Quantity: 300 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Irbesartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-284
Application NumberANDA204740
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2021
FDA Product Classification
INGREDIENTS (7)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
IRBESARTANActive
Quantity: 75 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Irbesartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-285
Application NumberANDA204740
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2021
FDA Product Classification
INGREDIENTS (7)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
IRBESARTANActive
Quantity: 150 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT