Losartan Potassium and Hydrochlorothiazide

Product NDC
83008-086
11-digit product format
830080086
Labeler code
83008
Product ID
83008-086_b2463971-2003-4f2a-9e1b-fb50c3dd8eaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA204901
Marketing category
ANDA
Marketing start
2024-08-28
Marketing end
2027-03-21
Substance
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength
25; 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
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 startMarketing endSampleExclude flagStatus
83008-086-908300800869090 TABLET, FILM COATED in 1 BOTTLE (83008-086-90) 2024-08-282027-03-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Losartan Potassium and HydrochlorothiazideQuality Care Products, LLC2024-12-19HUMAN PRESCRIPTION DRUG LABEL4