ENALAPRIL MALEATE
Enalapril Maleate
Approved
Approval ID
53ac99fe-8ff3-4a6f-b90e-d602e1019acb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 24, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-489
Application NumberANDA075483
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENALAPRIL MALEATE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2010
FDA Product Classification
INGREDIENTS (2)
ENALAPRIL MALEATEActive
Quantity: 20 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIM
STEARIC ACIDInactive
Quantity: 4.20 mg in 1 1
Code: 4ELV7Z65AP
Classification: IACT
ENALAPRIL MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-487
Application NumberANDA075483
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENALAPRIL MALEATE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2010
FDA Product Classification
INGREDIENTS (1)
ENALAPRIL MALEATEActive
Quantity: 5 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIM
ENALAPRIL MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-488
Application NumberANDA075483
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENALAPRIL MALEATE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2010
FDA Product Classification
INGREDIENTS (1)
ENALAPRIL MALEATEActive
Quantity: 10 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIM