triamterene and hydrochlorothiazide (68001-387)

Drug Facts

Product Profile

Brand Name triamterene and hydrochlorothiazide

Generic Name triamterene and hydrochlorothiazide

Labeler bluepoint laboratories

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 25 mg/1, triamterene 37.5 mg/1

Manufacturer

BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-387

Product ID 68001-387_14ca7c10-0f45-bfdf-e063-6294a90ad956

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA073449

Listing Expiration 2026-12-31

Marketing Start 2019-06-18

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 68001387

Hyphenated Format 68001-387

Supplemental Identifiers

RxCUI

310812 310818

UPC

0368001387002 0368001388009

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 ANDA073449 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
37.5 mg/1

source: ndc

Packaging

500 TABLET in 1 BOTTLE, PLASTIC (68001-387-03)

source: ndc

Packages (1)

68001-387-03 500 TABLET in 1 BOTTLE, PLASTIC (68001-387-03)

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": "14ca7c10-0f45-bfdf-e063-6294a90ad956", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000008859", "N0000175418"], "upc": ["0368001387002", "0368001388009"], "unii": ["0J48LPH2TH", "WS821Z52LQ"], "rxcui": ["310812", "310818"], "spl_set_id": ["b8a55c23-b509-4790-88fa-9dc9bacd4bbe"], "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": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (68001-387-03)", "package_ndc": "68001-387-03", "marketing_start_date": "20190618"}], "brand_name": "Triamterene and Hydrochlorothiazide", "product_id": "68001-387_14ca7c10-0f45-bfdf-e063-6294a90ad956", "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": "68001-387", "generic_name": "Triamterene and Hydrochlorothiazide", "labeler_name": "BluePoint Laboratories", "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": "ANDA073449", "marketing_category": "ANDA", "marketing_start_date": "20190618", "listing_expiration_date": "20261231"}