Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Micardis
Product Details
NDC Product Code
54868-4605Application Number
NDA020850Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
February 14, 2012SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUYClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TelmisartanActive
Code: U5SYW473RQClass: ACTIBQuantity: 80 mg in 1 1
Micardis
Product Details
NDC Product Code
54868-4539Application Number
NDA020850Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
February 14, 2012POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUYClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
TelmisartanActive
Code: U5SYW473RQClass: ACTIBQuantity: 40 mg in 1 1
Micardis
Product Details
NDC Product Code
54868-6193Application Number
NDA020850Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
February 14, 2012POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
TelmisartanActive
Code: U5SYW473RQClass: ACTIBQuantity: 20 mg in 1 1
MEGLUMINEInactive
Code: 6HG8UB2MUYClass: IACT