Trandolapril
Approved
Approval ID
ad682e7f-e0f5-4f11-8e05-dd308cbf6a05
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 9, 2010
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.
Trandolapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6061
Application NumberANDA077256
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trandolapril
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2010
FDA Product Classification
INGREDIENTS (8)
TRANDOLAPRILActive
Quantity: 4 mg in 1 1
Code: 1T0N3G9CRC
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT