Enalapril Maleate
ENALAPRIL MALEATE TABLETS USP, 2.5 mg, 5 mg, 10 mg and 20 mgRx only
Approved
Approval ID
d42cd274-ee43-4be7-b006-24dce0fb6cf6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 2
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 Code53808-0648
Application NumberANDA075479
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enalapril Maleate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2010
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 20 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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 Code53808-0663
Application NumberANDA075479
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enalapril Maleate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2010
FDA Product Classification
INGREDIENTS (5)
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
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT