Enalapril Maleate
Enalapril Maleate Tablets, USP
Approved
Approval ID
f3754f29-9b75-4e2c-9c28-b3479f5bf906
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 2, 2023
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.
Enalapril Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-6712
Application NumberANDA075657
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enalapril Maleate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2023
FDA Product Classification
INGREDIENTS (5)
ENALAPRIL MALEATEActive
Quantity: 10 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
Sodium BicarbonateInactive
Code: 8MDF5V39QO
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT