Trandolapril
TRANDOLAPRIL TABLETS USP
Approved
Approval ID
10f25119-9970-46fe-bf36-6fec6064895b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 26, 2018
Manufacturers
FDA
Epic Pharma, LLC
DUNS: 827915443
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trandolapril Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-054
Application NumberANDA078508
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trandolapril Tablets
Product Specifications
Route of AdministrationORAL
Effective DateJuly 26, 2018
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRANDOLAPRILActive
Quantity: 4 mg in 1 1
Code: 1T0N3G9CRC
Classification: ACTIB
Trandolapril Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-053
Application NumberANDA078508
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trandolapril Tablets
Product Specifications
Route of AdministrationORAL
Effective DateJuly 26, 2018
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TRANDOLAPRILActive
Quantity: 2 mg in 1 1
Code: 1T0N3G9CRC
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Trandolapril Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-052
Application NumberANDA078508
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trandolapril Tablets
Product Specifications
Route of AdministrationORAL
Effective DateJuly 26, 2018
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TRANDOLAPRILActive
Quantity: 1 mg in 1 1
Code: 1T0N3G9CRC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT