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Enalapril Maleate and Hydrochlorothiazide

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP

Approved
Approval ID

c1d62153-8622-40de-a20b-3faecd718736

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 20, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

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 Code21695-780
Application NumberANDA075788
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enalapril Maleate and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2008
FDA Product Classification

INGREDIENTS (7)

lactoseInactive
Code: J2B2A4N98G
Classification: IACT
sodium bicarbonateInactive
Code: 8MDF5V39QO
Classification: IACT
HydrochlorothiazideActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
FERROUS OXIDEInactive
Code: G7036X8B5H
Classification: IACT
Enalapril MaleateActive
Quantity: 10 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT

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Enalapril Maleate and Hydrochlorothiazide - FDA Drug Approval Details