triamterene and hydrochlorothiazide (71610-602)

Drug Facts

Product Profile

Brand Name triamterene and hydrochlorothiazide

Generic Name triamterene and hydrochlorothiazide

Labeler aphena pharma solutions - tennessee, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 25 mg/1, triamterene 37.5 mg/1

Manufacturer

Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-602

Product ID 71610-602_a7634afa-7ea2-43dd-8fe4-520d827c2725

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA208360

Listing Expiration 2026-12-31

Marketing Start 2018-09-04

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 71610602

Hyphenated Format 71610-602

Supplemental Identifiers

RxCUI

310812

UNII

0J48LPH2TH WS821Z52LQ

NUI

N0000175359 N0000175419 M0471776 N0000008859 N0000175418

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 ANDA208360 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
37.5 mg/1

source: ndc

Packaging

90 TABLET in 1 BOTTLE (71610-602-60)

source: ndc

Packages (1)

71610-602-60 90 TABLET in 1 BOTTLE (71610-602-60)

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": "a7634afa-7ea2-43dd-8fe4-520d827c2725", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000008859", "N0000175418"], "unii": ["0J48LPH2TH", "WS821Z52LQ"], "rxcui": ["310812"], "spl_set_id": ["236dead0-16d5-4383-860f-30743730a088"], "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": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-602-60)", "package_ndc": "71610-602-60", "marketing_start_date": "20211007"}], "brand_name": "triamterene and hydrochlorothiazide", "product_id": "71610-602_a7634afa-7ea2-43dd-8fe4-520d827c2725", "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": "71610-602", "generic_name": "triamterene and hydrochlorothiazide", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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": "ANDA208360", "marketing_category": "ANDA", "marketing_start_date": "20180904", "listing_expiration_date": "20261231"}