Valsartan and Hydrochlorothiazide

Product NDC
63187-427
11-digit product format
631870427
Labeler code
63187
Product ID
63187-427_7c22aa60-186e-4ff5-b375-e3022bca2706
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; 320 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
63187-427-306318704273030 TABLET, FILM COATED in 1 BOTTLE (63187-427-30) 2016-06-01NoNoHistorical
63187-427-606318704276060 TABLET, FILM COATED in 1 BOTTLE (63187-427-60) 2016-06-01NoNoHistorical
63187-427-906318704279090 TABLET, FILM COATED in 1 BOTTLE (63187-427-90) 2016-06-01NoNoHistorical

Related DailyMed Labels

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