ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Approved
Approval ID
e435ee3d-20b1-449b-8704-b2bf2a579af8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5100
Application NumberANDA076486
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2009
FDA Product Classification
INGREDIENTS (5)
ENALAPRIL MALEATEActive
Quantity: 10 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5503
Application NumberANDA076486
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2009
FDA Product Classification
INGREDIENTS (5)
ENALAPRIL MALEATEActive
Quantity: 5 g in 1 1
Code: 9O25354EPJ
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT