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
0898f423-0aa9-409c-8d4e-1349b59141d1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 3, 2022
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
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 Code46708-440
Application NumberANDA091236
Product Classification
M
Marketing Category
C73584
G
Generic Name
IRBESARTAN
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2022
FDA Product Classification
INGREDIENTS (5)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
IRBESARTANActive
Quantity: 150 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
IRBESARTAN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-439
Application NumberANDA091236
Product Classification
M
Marketing Category
C73584
G
Generic Name
IRBESARTAN
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2022
FDA Product Classification
INGREDIENTS (5)
IRBESARTANActive
Quantity: 75 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
IRBESARTAN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-441
Application NumberANDA091236
Product Classification
M
Marketing Category
C73584
G
Generic Name
IRBESARTAN
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2022
FDA Product Classification
INGREDIENTS (5)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
IRBESARTANActive
Quantity: 300 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT