Enalapril Maleate
ENALAPRIL MALEATE TABLETS, USP Rx only
Approved
Approval ID
e109e7b1-4650-4416-9d89-7c1185d5cf48
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 15, 2018
Manufacturers
FDA
Northstar RxLLC
DUNS: 830546433
Products 4
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 Code16714-443
Application NumberANDA075496
Product Classification
M
Marketing Category
C73584
G
Generic Name
enalapril maleate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2017
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 5 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
enalapril maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-442
Application NumberANDA075496
Product Classification
M
Marketing Category
C73584
G
Generic Name
enalapril maleate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2017
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 2.5 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
enalapril maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-444
Application NumberANDA075459
Product Classification
M
Marketing Category
C73584
G
Generic Name
enalapril maleate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2017
FDA Product Classification
INGREDIENTS (8)
ENALAPRIL MALEATEActive
Quantity: 10 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
enalapril maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-445
Application NumberANDA075459
Product Classification
M
Marketing Category
C73584
G
Generic Name
enalapril maleate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2017
FDA Product Classification
INGREDIENTS (8)
ENALAPRIL MALEATEActive
Quantity: 20 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT