Valsartan and Hydrochlorothiazide

Product NDC
71205-249
11-digit product format
712050249
Labeler code
71205
Product ID
71205-249_3129e59a-5814-4050-bd80-29f469ca66a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078946
Marketing category
ANDA
Marketing start
2013-03-21
Substance
HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength
12.5; 80 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
80M03YXJ7IVALSARTAN137862-53-4VALSARTAN

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-249-307120502493030 TABLET, FILM COATED in 1 BOTTLE (71205-249-30) 2019-04-01NoNoHistorical
71205-249-607120502496060 TABLET, FILM COATED in 1 BOTTLE (71205-249-60) 2019-04-01NoNoHistorical
71205-249-907120502499090 TABLET, FILM COATED in 1 BOTTLE (71205-249-90) 2019-04-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Valsartan and HydrochlorothiazideProficient Rx LP2019-10-01HUMAN PRESCRIPTION DRUG LABEL2