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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

068224c4-a34d-32d7-bb2a-7eed44ccf7d3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 23, 2022

Manufacturers
FDA

Jubilant Cadista Pharmacuticals Inc.

DUNS: 118694141

FDA

Jubilant Cadista Pharmaceuticals Inc.

DUNS: 022490515

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 Code59746-447
Application NumberANDA203534
Product Classification
M
Marketing Category
C73584
G
Generic Name
IRBESARTAN
Product Specifications
Route of AdministrationORAL
Effective DateJune 23, 2022
FDA Product Classification

INGREDIENTS (7)

irbesartanActive
Quantity: 75 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT

IRBESARTAN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59746-448
Application NumberANDA203534
Product Classification
M
Marketing Category
C73584
G
Generic Name
IRBESARTAN
Product Specifications
Route of AdministrationORAL
Effective DateJune 23, 2022
FDA Product Classification

INGREDIENTS (7)

irbesartanActive
Quantity: 150 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
silicon dioxideInactive
Code: ETJ7Z6XBU4
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 Code59746-449
Application NumberANDA203534
Product Classification
M
Marketing Category
C73584
G
Generic Name
IRBESARTAN
Product Specifications
Route of AdministrationORAL
Effective DateJune 23, 2022
FDA Product Classification

INGREDIENTS (7)

Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
irbesartanActive
Quantity: 300 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT

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