triamterene and hydrochlorothiazide (0591-0348)

Drug Facts

Product Profile

Brand Name triamterene and hydrochlorothiazide

Generic Name triamterene and hydrochlorothiazide

Labeler actavis pharma, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 50 mg/1, triamterene 75 mg/1

Manufacturer

Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-0348

Product ID 0591-0348_31975473-b876-48d4-81f4-b322137d8900

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA071851

Listing Expiration 2026-12-31

Marketing Start 1993-09-23

Pharmacologic Class

Established (EPC)

thiazide diuretic [epc] potassium-sparing diuretic [epc]

Chemical Structure

thiazides [cs]

Physiologic Effect

increased diuresis [pe] decreased renal k+ excretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05910348

Hyphenated Format 0591-0348

Supplemental Identifiers

RxCUI

310812 310818

UPC

0305910424015

UNII

0J48LPH2TH WS821Z52LQ

NUI

N0000175359 N0000175419 M0471776 N0000008859 N0000175418

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 triamterene and hydrochlorothiazide (source: ndc)

Generic Name triamterene and hydrochlorothiazide (source: ndc)

Application Number ANDA071851 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

50 mg/1
75 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE, PLASTIC (0591-0348-01)
500 TABLET in 1 BOTTLE, PLASTIC (0591-0348-05)
1000 TABLET in 1 BOTTLE, PLASTIC (0591-0348-10)

source: ndc

Packages (3)

0591-0348-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-0348-01) 0591-0348-05 500 TABLET in 1 BOTTLE, PLASTIC (0591-0348-05) 0591-0348-10 1000 TABLET in 1 BOTTLE, PLASTIC (0591-0348-10)

Ingredients (2)

hydrochlorothiazide (50 mg/1) triamterene (75 mg/1)

Linked Drug Pages (1)

Triamterene and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "31975473-b876-48d4-81f4-b322137d8900", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000008859", "N0000175418"], "upc": ["0305910424015"], "unii": ["0J48LPH2TH", "WS821Z52LQ"], "rxcui": ["310812", "310818"], "spl_set_id": ["abf2fe45-8b69-4d3c-981e-289c0aa3e98b"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]", "Decreased Renal K+ Excretion [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]", "Potassium-sparing Diuretic [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0591-0348-01)", "package_ndc": "0591-0348-01", "marketing_start_date": "19930923"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (0591-0348-05)", "package_ndc": "0591-0348-05", "marketing_start_date": "19930923"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (0591-0348-10)", "package_ndc": "0591-0348-10", "marketing_start_date": "19930923"}], "brand_name": "Triamterene and Hydrochlorothiazide", "product_id": "0591-0348_31975473-b876-48d4-81f4-b322137d8900", "dosage_form": "TABLET", "pharm_class": ["Decreased Renal K+ Excretion [PE]", "Increased Diuresis [PE]", "Increased Diuresis [PE]", "Potassium-sparing Diuretic [EPC]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "0591-0348", "generic_name": "Triamterene and Hydrochlorothiazide", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Triamterene and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "50 mg/1"}, {"name": "TRIAMTERENE", "strength": "75 mg/1"}], "application_number": "ANDA071851", "marketing_category": "ANDA", "marketing_start_date": "19930923", "listing_expiration_date": "20261231"}