Enalapril maleate oral solution
These highlights do not include all the information needed to use ENALAPRIL MALEATE ORAL SOLUTION safely and effectively. See full prescribing information for ENALAPRIL MALEATE ORAL SOLUTION. ENALAPRIL MALEATE oral solution Initial U.S. Approval: 1985
Approved
Approval ID
9391b8d8-2217-4838-8976-1a5ad90ef4ca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
Bionpharma Inc.
DUNS: 079637826
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 Code69452-237
Application NumberANDA212408
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enalapril maleate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (10)
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BERRYInactive
Code: FV3431923Z
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 1 mg in 1 mL
Code: 9O25354EPJ
Classification: ACTIB