Micardis
These highlights do not include all the information needed to use MICARDIS safely and effectively. See full prescribing information for MICARDIS. MICARDIS (telmisartan) Tablets Initial U.S. Approval: 1998
Approved
Approval ID
3bb7bc69-7752-4c16-9c60-e61eb5355a4d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4605
Application NumberNDA020850
Product Classification
M
Marketing Category
C73594
G
Generic Name
TELMISARTAN
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (6)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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 Code54868-4539
Application NumberNDA020850
Product Classification
M
Marketing Category
C73594
G
Generic Name
TELMISARTAN
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (6)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TELMISARTANActive
Quantity: 40 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
TELMISARTAN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6193
Application NumberNDA020850
Product Classification
M
Marketing Category
C73594
G
Generic Name
TELMISARTAN
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (6)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TELMISARTANActive
Quantity: 20 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT