Trandolapril
Trandolapril Tablets USP Rx only
Approved
Approval ID
0107d19a-b43a-4a36-8b8c-4dfc247630e9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2019
Manufacturers
FDA
Rising Health, LLC
DUNS: 080500961
Products 3
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 Code57237-089
Application NumberANDA078438
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trandolapril
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2019
FDA Product Classification
INGREDIENTS (8)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRANDOLAPRILActive
Quantity: 1 mg in 1 1
Code: 1T0N3G9CRC
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Trandolapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57237-091
Application NumberANDA078438
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trandolapril
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2019
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRANDOLAPRILActive
Quantity: 4 mg in 1 1
Code: 1T0N3G9CRC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Trandolapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57237-090
Application NumberANDA078438
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trandolapril
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2019
FDA Product Classification
INGREDIENTS (8)
TRANDOLAPRILActive
Quantity: 2 mg in 1 1
Code: 1T0N3G9CRC
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT