Telmisartan
These highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
a075633a-2a2a-4e88-8ede-b49a3920a16c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2023
Manufacturers
FDA
Modavar Pharmaceuticals LLC
DUNS: 858949204
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Telmisartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72241-016
Application NumberANDA208605
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2023
FDA Product Classification
INGREDIENTS (6)
TELMISARTANActive
Quantity: 40 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Telmisartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72241-017
Application NumberANDA208605
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2023
FDA Product Classification
INGREDIENTS (6)
TELMISARTANActive
Quantity: 80 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Telmisartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72241-015
Application NumberANDA208605
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2023
FDA Product Classification
INGREDIENTS (6)
TELMISARTANActive
Quantity: 20 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT