triamterene and hydrochlorothiazide (33342-467)

Drug Facts

Product Profile

Brand Name triamterene and hydrochlorothiazide

Generic Name triamterene and hydrochlorothiazide

Labeler macleods pharmaceuticals limited

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

hydrochlorothiazide 25 mg/1, triamterene 37.5 mg/1

Manufacturer

Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-467

Product ID 33342-467_96024781-b8d8-452f-ab9c-6c9ab07b34ea

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214611

Listing Expiration 2026-12-31

Marketing Start 2025-01-28

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 33342467

Hyphenated Format 33342-467

Supplemental Identifiers

RxCUI

198316

UPC

0333342467119 0333342467447

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 ANDA214611 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
37.5 mg/1

source: ndc

Packaging

100 CAPSULE in 1 BOTTLE (33342-467-11)
1000 CAPSULE in 1 BOTTLE (33342-467-44)

source: ndc

Packages (2)

33342-467-11 100 CAPSULE in 1 BOTTLE (33342-467-11) 33342-467-44 1000 CAPSULE in 1 BOTTLE (33342-467-44)

Ingredients (2)

hydrochlorothiazide (25 mg/1) triamterene (37.5 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": "96024781-b8d8-452f-ab9c-6c9ab07b34ea", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000008859", "N0000175418"], "upc": ["0333342467119", "0333342467447"], "unii": ["0J48LPH2TH", "WS821Z52LQ"], "rxcui": ["198316"], "spl_set_id": ["e05e3314-5520-4bbd-b7f0-623afd9ba569"], "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": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (33342-467-11)", "package_ndc": "33342-467-11", "marketing_start_date": "20250128"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (33342-467-44)", "package_ndc": "33342-467-44", "marketing_start_date": "20250128"}], "brand_name": "Triamterene and Hydrochlorothiazide", "product_id": "33342-467_96024781-b8d8-452f-ab9c-6c9ab07b34ea", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Renal K+ Excretion [PE]", "Increased Diuresis [PE]", "Increased Diuresis [PE]", "Potassium-sparing Diuretic [EPC]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "33342-467", "generic_name": "Triamterene and Hydrochlorothiazide", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Triamterene and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "TRIAMTERENE", "strength": "37.5 mg/1"}], "application_number": "ANDA214611", "marketing_category": "ANDA", "marketing_start_date": "20250128", "listing_expiration_date": "20261231"}