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 useInitial U.S. Approval: 1997
Approved
Approval ID
a7c093c2-3eef-4956-8a14-c36aada0304f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
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 Code68180-412
Application NumberANDA201531
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2023
FDA Product Classification
INGREDIENTS (7)
IRBESARTANActive
Quantity: 300 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
Irbesartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-411
Application NumberANDA201531
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2023
FDA Product Classification
INGREDIENTS (7)
IRBESARTANActive
Quantity: 150 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
Irbesartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-410
Application NumberANDA201531
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2023
FDA Product Classification
INGREDIENTS (7)
IRBESARTANActive
Quantity: 75 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT