Losartan Potassium and Hydrochlorothiazide

Product NDC
52343-117
11-digit product format
523430117
Labeler code
52343
Product ID
52343-117_8429d375-9e85-4dc4-870a-fc609e212a96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ACETRIS HEALTH, LLC
Application
ANDA091629
Marketing category
ANDA
Marketing start
2010-10-06
Marketing end
0000-00-00
Substance
LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
Active strength
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52343-117-30EA - Each52343-1170ee23b42-63e3-4061-a3cb-61e45c6d11ef12016-05-16
52343-117-90EA - Each52343-11775119fde-5abd-446a-9eea-c361c6846f6612016-05-16
52343-117-99EA - Each52343-117a44fbe40-84c4-4c76-b625-1feb989867a112016-05-16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52343-117-305234301173030 TABLET, FILM COATED in 1 BOTTLE (52343-117-30) 2010-10-060000-00-00NoNoCurrent
52343-117-905234301179090 TABLET, FILM COATED in 1 BOTTLE (52343-117-90) 2010-10-060000-00-00NoNoCurrent
52343-117-99523430117991000 TABLET, FILM COATED in 1 BOTTLE (52343-117-99) 2010-10-060000-00-00NoNoCurrent