benazepril hydrochloride and hydrochlorothiazide (68462-578)

Drug Facts

Product Profile

Brand Name benazepril hydrochloride and hydrochlorothiazide

Generic Name benazepril hydrochloride and hydrochlorothiazide

Labeler glenmark pharmaceuticals inc., usa

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

benazepril hydrochloride 20 mg/1, hydrochlorothiazide 12.5 mg/1

Manufacturer

Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-578

Product ID 68462-578_51b0aed8-a229-4d2c-8fdf-aa957fddc41b

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA076631

Listing Expiration 2026-12-31

Marketing Start 2004-02-11

Pharmacologic Class

Established (EPC)

thiazide diuretic [epc]

Chemical Structure

thiazides [cs]

Physiologic Effect

increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462578

Hyphenated Format 68462-578

Supplemental Identifiers

RxCUI

898362 898367 898372 898378

UPC

0368462579015 0368462576014 0368462578018

UNII

0J48LPH2TH N1SN99T69T

NUI

N0000175359 N0000175419 M0471776

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name benazepril hydrochloride and hydrochlorothiazide (source: ndc)

Generic Name benazepril hydrochloride and hydrochlorothiazide (source: ndc)

Application Number ANDA076631 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1
12.5 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE (68462-578-01)

source: ndc

Packages (1)

68462-578-01 100 TABLET, FILM COATED in 1 BOTTLE (68462-578-01)

Ingredients (2)

benazepril hydrochloride (20 mg/1) hydrochlorothiazide (12.5 mg/1)

Linked Drug Pages (1)

Benazepril Hydrochloride and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "51b0aed8-a229-4d2c-8fdf-aa957fddc41b", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0368462579015", "0368462576014", "0368462578018"], "unii": ["0J48LPH2TH", "N1SN99T69T"], "rxcui": ["898362", "898367", "898372", "898378"], "spl_set_id": ["51b0aed8-a229-4d2c-8fdf-aa957fddc41b"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68462-578-01)", "package_ndc": "68462-578-01", "marketing_start_date": "20231130"}], "brand_name": "Benazepril Hydrochloride and Hydrochlorothiazide", "product_id": "68462-578_51b0aed8-a229-4d2c-8fdf-aa957fddc41b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin Converting Enzyme Inhibitor [EPC]", "Angiotensin-converting Enzyme Inhibitors [MoA]", "Decreased Blood Pressure [PE]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "68462-578", "generic_name": "Benazepril Hydrochloride and Hydrochlorothiazide", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benazepril Hydrochloride and Hydrochlorothiazide", "active_ingredients": [{"name": "BENAZEPRIL HYDROCHLORIDE", "strength": "20 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA076631", "marketing_category": "ANDA", "marketing_start_date": "20040211", "listing_expiration_date": "20261231"}