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
2113a901-2612-4557-b86d-3afc006fb8bb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 16, 2021
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
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 Code65862-639
Application NumberANDA203081
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2021
FDA Product Classification
INGREDIENTS (9)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
IRBESARTANActive
Quantity: 300 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Irbesartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-637
Application NumberANDA203081
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2021
FDA Product Classification
INGREDIENTS (9)
IRBESARTANActive
Quantity: 75 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Irbesartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-638
Application NumberANDA203081
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2021
FDA Product Classification
INGREDIENTS (9)
IRBESARTANActive
Quantity: 150 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT