Enalapril Maleate
ENALAPRIL MALEATE TABLETS USP 2.5 mg, 5 mg, 10 mg and 20 mgRx only
Approved
Approval ID
62fb98cc-d3c0-4408-8b95-78d56dfdb9ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 11, 2013
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 1
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 Code53808-0833
Application NumberANDA075479
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enalapril Maleate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2013
FDA Product Classification
INGREDIENTS (11)
ENALAPRIL MALEATEActive
Quantity: 2.5 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT