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
9644fa38-dd28-4888-9d55-80967c4fc8d7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
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 Code50090-6938
Application NumberANDA202910
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
IRBESARTANActive
Quantity: 300 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB