Losartan Potassium and Hydrochlorothiazide

Product NDC
82804-103
11-digit product format
828040103
Labeler code
82804
Product ID
82804-103_c6ed6f74-0eca-4f99-8c7e-dd3f56167f01
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; 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
82804-103-908280401039090 TABLET, FILM COATED in 1 BOTTLE (82804-103-90) 2024-05-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Losartan Potassium and HydrochlorothiazideProficient Rx LP2024-05-01HUMAN PRESCRIPTION DRUG LABEL1