Enalapril maleate
Rx only
Approved
Approval ID
ed7536f1-9a7d-4519-e053-2a95a90a4a65
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2023
Manufacturers
FDA
Legacy Pharmaceutical Packaging, LLC
DUNS: 143213275
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Enalapril maleate
PRODUCT DETAILS
NDC Product Code68645-605
Application NumberANDA075479
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 12, 2023
Generic NameEnalapril maleate
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 5 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Enalapril maleate
PRODUCT DETAILS
NDC Product Code68645-607
Application NumberANDA075479
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 12, 2023
Generic NameEnalapril maleate
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 20 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Enalapril maleate
PRODUCT DETAILS
NDC Product Code68645-606
Application NumberANDA075479
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 12, 2023
Generic NameEnalapril maleate
INGREDIENTS (9)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 10 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT