Enalapril maleate and hydrochlorothiazide
ENALAPRIL MALEATE ANDHYDROCHLOROTHIAZIDE TABLETS, USP
Approved
Approval ID
ed4a55a6-cd6a-c74a-cb93-4b45641691a0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2010
Manufacturers
FDA
Dr. Reddy's Laboratories Limited
DUNS: 650562841
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 Code55111-134
Application NumberANDA075909
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enalapril maleate and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2010
FDA Product Classification
INGREDIENTS (6)
enalapril maleateActive
Quantity: 10 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
hydrochlorothiazideActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
zinc stearateInactive
Code: H92E6QA4FV
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
Enalapril maleate and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55111-133
Application NumberANDA075909
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enalapril maleate and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2010
FDA Product Classification
INGREDIENTS (6)
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
zinc stearateInactive
Code: H92E6QA4FV
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
enalapril maleateActive
Quantity: 5 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
hydrochlorothiazideActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB