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, USP for oral use Initial U.S. Approval: 1997
Approved
Approval ID
0f3408b4-44be-4a92-a59f-9b5a9716bc9a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2016
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
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 Code31722-161
Application NumberANDA204774
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2016
FDA Product Classification
INGREDIENTS (8)
IRBESARTANActive
Quantity: 150 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Irbesartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-162
Application NumberANDA204774
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2016
FDA Product Classification
INGREDIENTS (8)
IRBESARTANActive
Quantity: 300 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Irbesartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-160
Application NumberANDA204774
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2016
FDA Product Classification
INGREDIENTS (8)
IRBESARTANActive
Quantity: 75 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT