Trandolapril
TRANDOLAPRIL TABLETS Rx only
Approved
Approval ID
9b6b2156-7f20-47a1-80e5-e0db3188769e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 16, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-4128
Application NumberANDA077522
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trandolapril
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2019
FDA Product Classification
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TRANDOLAPRILActive
Quantity: 1 mg in 1 1
Code: 1T0N3G9CRC
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT