Losartan Potassium and Hydrochlorothiazide

Product NDC
82804-239
11-digit product format
828040239
Labeler code
82804
Product ID
82804-239_be81ba65-c434-4287-97d3-cd11d6031636
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204901
Marketing category
ANDA
Marketing start
2018-02-15
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
82804-239-308280402393030 TABLET, FILM COATED in 1 BOTTLE (82804-239-30) 2025-09-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Losartan Potassium and HydrochlorothiazideProficient Rx LP2025-09-01HUMAN PRESCRIPTION DRUG LABEL1