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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68645-605
Application NumberANDA075479
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enalapril maleate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68645-607
Application NumberANDA075479
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enalapril maleate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68645-606
Application NumberANDA075479
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enalapril maleate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2023
FDA Product Classification
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