TELMISARTAN
Telmisartan Tablets, USP These highlights do not include all the information needed to use TELMISARTAN TABLETS, USP safely and effectively. See full prescribing information for TELMISARTAN TABLETS, USP. TELMISARTAN tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
beaaf383-730f-4411-b5e7-15c32b53a338
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 10, 2023
Manufacturers
FDA
Chartwell RX, LLC.
DUNS: 079394054
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 Code62135-535
Application NumberANDA078710
Product Classification
M
Marketing Category
C73584
G
Generic Name
TELMISARTAN
Product Specifications
Route of AdministrationORAL
Effective DateMarch 10, 2023
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
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 Code62135-537
Application NumberANDA078710
Product Classification
M
Marketing Category
C73584
G
Generic Name
TELMISARTAN
Product Specifications
Route of AdministrationORAL
Effective DateMarch 10, 2023
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TELMISARTANActive
Quantity: 80 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
TELMISARTAN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-536
Application NumberANDA078710
Product Classification
M
Marketing Category
C73584
G
Generic Name
TELMISARTAN
Product Specifications
Route of AdministrationORAL
Effective DateMarch 10, 2023
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TELMISARTANActive
Quantity: 40 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT