Trandolapril
Trandolapril Tablets USP Rx only
Approved
Approval ID
6f25ed16-e5e9-4170-b4b4-3b460887779e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 4, 2022
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
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 Code65862-166
Application NumberANDA078438
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trandolapril
Product Specifications
Route of AdministrationORAL
Effective DateJuly 4, 2022
FDA Product Classification
INGREDIENTS (8)
TRANDOLAPRILActive
Quantity: 4 mg in 1 1
Code: 1T0N3G9CRC
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
Trandolapril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-164
Application NumberANDA078438
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trandolapril
Product Specifications
Route of AdministrationORAL
Effective DateJuly 4, 2022
FDA Product Classification
INGREDIENTS (8)
TRANDOLAPRILActive
Quantity: 1 mg in 1 1
Code: 1T0N3G9CRC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
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 Code65862-165
Application NumberANDA078438
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trandolapril
Product Specifications
Route of AdministrationORAL
Effective DateJuly 4, 2022
FDA Product Classification
INGREDIENTS (8)
TRANDOLAPRILActive
Quantity: 2 mg in 1 1
Code: 1T0N3G9CRC
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 7/4/2022
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 mg (100 Tablets Bottle)
NDC 65862-166-01
Rx only
Trandolapril
** Tablets USP**
4 mg
AUROBINDO 100 Tablets
****