Enalapril Maleate
Enalapril Maleate Tablets, USP
Approved
Approval ID
0f7c3734-e05b-7082-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 19, 2015
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
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 Code10544-633
Application NumberANDA075657
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enalapril Maleate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2015
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 20 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Enalapril Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10544-632
Application NumberANDA075657
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enalapril Maleate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2015
FDA Product Classification
INGREDIENTS (6)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 10 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT