Valsartan and Hydrochlorothiazide

Product NDC
63187-571
11-digit product format
631870571
Labeler code
63187
Product ID
63187-571_a543bb07-d767-4b72-afe8-72fb969b13b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202519
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
63187-571-306318705713030 TABLET, FILM COATED in 1 BOTTLE (63187-571-30) 2018-12-01NoNoHistorical
63187-571-606318705716060 TABLET, FILM COATED in 1 BOTTLE (63187-571-60) 2018-12-01NoNoHistorical
63187-571-906318705719090 TABLET, FILM COATED in 1 BOTTLE (63187-571-90) 2018-12-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Valsartan and HydrochlorothiazideProficient Rx LP2019-11-01HUMAN PRESCRIPTION DRUG LABEL3