Teveten HCT
TEVETEN HCT (eprosartan mesylate/hydrochlorothiazide)600/12.5mg 600/25mg
Approved
Approval ID
b1dfcac3-ef66-4d3e-9d58-37d3f516eb31
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Eprosartan Mesylate and Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5281
Application NumberNDA021268
Product Classification
M
Marketing Category
C73594
G
Generic Name
Eprosartan Mesylate and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2012
FDA Product Classification
INGREDIENTS (14)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
EPROSARTAN MESYLATEActive
Quantity: 600 mg in 1 1
Code: 8N2L1NX8S3
Classification: ACTIM
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT