losartan potassium and hydrochlorothiazide

Product NDC
71335-2827
11-digit product format
713352827
Labeler code
71335
Product ID
71335-2827_41d8c6ba-7b9a-707f-e063-6394a90ae778
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204832
Marketing category
ANDA
Marketing start
2017-07-21
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
71335-2827-17133528270190 TABLET, FILM COATED in 1 BOTTLE (71335-2827-1) 2025-10-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
losartan potassium and hydrochlorothiazideBryant Ranch Prepack2025-10-23HUMAN PRESCRIPTION DRUG LABEL100