ENALAPRIL MALEATE
Approved
Approval ID
66f5c697-4daa-4b5f-8ee2-40fc70960459
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2010
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
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 Code67046-160
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
ENALAPRIL MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-161
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 Code67046-156
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