Telmisartan
These highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. for oral use Initial U.S. Approval: 1998
Approved
Approval ID
f08eafa5-cec5-4048-8e52-f8140a81ef9f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2019
Manufacturers
FDA
Hisun Pharmaceuticals USA, Inc.
DUNS: 961628505
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 Code42658-135
Application NumberANDA207843
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2019
FDA Product Classification
INGREDIENTS (8)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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 Code42658-136
Application NumberANDA207843
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2019
FDA Product Classification
INGREDIENTS (8)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TELMISARTANActive
Quantity: 40 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
Telmisartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42658-137
Application NumberANDA207843
Product Classification
M
Marketing Category
C73584
G
Generic Name
Telmisartan
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2019
FDA Product Classification
INGREDIENTS (8)
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TELMISARTANActive
Quantity: 80 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT