Telmisartan
Telmisartan Tablets, USP 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
71902893-55da-4286-8b25-b528641489ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
AvKARE
DUNS: 796560394
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 Code42291-791
Application NumberANDA204415
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (7)
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TELMISARTANActive
Quantity: 40 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Telmisartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-790
Application NumberANDA204415
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TELMISARTANActive
Quantity: 20 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
Telmisartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-792
Application NumberANDA204415
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (7)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TELMISARTANActive
Quantity: 80 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT