quinapril hcl and hydrochlorothiazide (43386-711)

Drug Facts

Product Profile

Brand Name quinapril hcl and hydrochlorothiazide

Generic Name quinapril hcl and hydrochlorothiazide

Labeler lupin pharmaceuticals,inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-711

Product ID 43386-711_916f3e69-0d6e-4524-8abe-afb2e134eec2

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA076374

Listing Expiration 2026-12-31

Marketing Start 2011-07-15

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 43386711

Hyphenated Format 43386-711

Supplemental Identifiers

RxCUI

310796 310797 310809

UNII

0J48LPH2TH 33067B3N2M

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 quinapril hcl and hydrochlorothiazide (source: ndc)

Generic Name quinapril hcl and hydrochlorothiazide (source: ndc)

Application Number ANDA076374 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
20 mg/1

source: ndc

Packaging

500 TABLET in 1 BOTTLE (43386-711-05)
90 TABLET in 1 BOTTLE (43386-711-09)

source: ndc

Packages (2)

43386-711-05 500 TABLET in 1 BOTTLE (43386-711-05) 43386-711-09 90 TABLET in 1 BOTTLE (43386-711-09)

Ingredients (2)

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

Linked Drug Pages (1)

Quinapril HCL and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "916f3e69-0d6e-4524-8abe-afb2e134eec2", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "33067B3N2M"], "rxcui": ["310796", "310797", "310809"], "spl_set_id": ["383ecaa6-29c8-4280-a442-c47f101d7c88"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (43386-711-05)", "package_ndc": "43386-711-05", "marketing_start_date": "20110715"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43386-711-09)", "package_ndc": "43386-711-09", "marketing_start_date": "20110715"}], "brand_name": "Quinapril HCL and Hydrochlorothiazide", "product_id": "43386-711_916f3e69-0d6e-4524-8abe-afb2e134eec2", "dosage_form": "TABLET", "pharm_class": ["Angiotensin Converting Enzyme Inhibitor [EPC]", "Angiotensin-converting Enzyme Inhibitors [MoA]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "43386-711", "generic_name": "Quinapril HCL and Hydrochlorothiazide", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quinapril HCL and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "QUINAPRIL HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA076374", "marketing_category": "ANDA", "marketing_start_date": "20110715", "listing_expiration_date": "20261231"}