Losartan Potassium and Hydrochlorothiazide

Product NDC
72789-162
11-digit product format
727890162
Labeler code
72789
Product ID
72789-162_3caab5c5-0f4e-574c-e063-6394a90a5643
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA201845
Marketing category
ANDA
Marketing start
2012-10-30
Substance
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength
12.5; 50 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], 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
3ST302B24ALOSARTAN POTASSIUM124750-99-8LOSARTAN POTASSIUM

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-162-307278901623030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-162-30) 2021-01-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Losartan Potassium and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.2025-08-18HUMAN PRESCRIPTION DRUG LABEL17