Triamterene and Hydrochlorothiazide

Product NDC
55289-488
11-digit product format
552890488
Labeler code
55289
Product ID
55289-488_419ac74d-7d69-dca8-e063-6294a90a447d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA071851
Marketing category
ANDA
Marketing start
1993-09-23
Substance
HYDROCHLOROTHIAZIDE; TRIAMTERENE
Active strength
50; 75 mg/1; mg/1
Pharmacologic classes
Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0J48LPH2THHYDROCHLOROTHIAZIDE58-93-5HYDROCHLOROTHIAZIDE
WS821Z52LQTRIAMTERENE396-01-0TRIAMTERENE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55289-488-0155289048801100 TABLET in 1 BOTTLE, PLASTIC (55289-488-01) 100 tablet2011-02-16NoNoHistorical
55289-488-155528904881515 TABLET in 1 BOTTLE, PLASTIC (55289-488-15) 15 tablet2011-02-16NoNoHistorical
55289-488-305528904883030 TABLET in 1 BOTTLE, PLASTIC (55289-488-30) 30 tablet2011-02-16NoNoHistorical
55289-488-905528904889090 TABLET in 1 BOTTLE, PLASTIC (55289-488-90) 90 tablet2011-02-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Triamterene and Hydrochlorothiazide Tablets, USP Rx onlyPD-Rx Pharmaceuticals, Inc.2025-10-20HUMAN PRESCRIPTION DRUG LABEL21
Triamterene and Hydrochlorothiazide Tablets, USP Rx onlyPD-Rx Pharmaceuticals, Inc.2024-10-04HUMAN PRESCRIPTION DRUG LABEL20