Enalapril Maleate
Enalapril Maleate Tablets
Approved
Approval ID
505d5616-07bf-1e82-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 12, 2021
Manufacturers
FDA
NuCare Pharmaceuticals, Inc.
DUNS: 010632300
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 Code68071-3303
Application NumberNDA018998
Product Classification
M
Marketing Category
C73605
G
Generic Name
Enalapril Maleate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 12, 2021
FDA Product Classification
INGREDIENTS (8)
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STEARATEInactive
Code: QU7E2XA9TG
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 20 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT