Losartan Potassium and Hydrochlorothiazide

Product NDC
71335-2572
11-digit product format
713352572
Labeler code
71335
Product ID
71335-2572_367a96b9-9983-4c67-acea-7ab1f44ea7f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204901
Marketing category
ANDA
Marketing start
2018-02-15
Substance
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength
12.5; 100 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
71335-2572-17133525720130 TABLET, FILM COATED in 1 BOTTLE (71335-2572-1) 2025-02-05NoNoHistorical
71335-2572-27133525720290 TABLET, FILM COATED in 1 BOTTLE (71335-2572-2) 2025-02-05NoNoHistorical
71335-2572-371335257203120 TABLET, FILM COATED in 1 BOTTLE (71335-2572-3) 2025-02-05NoNoHistorical
71335-2572-471335257204100 TABLET, FILM COATED in 1 BOTTLE (71335-2572-4) 2025-02-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Losartan Potassium and HydrochlorothiazideBryant Ranch Prepack2025-02-05HUMAN PRESCRIPTION DRUG LABEL1