Valsartan and Hydrochlorothiazide

Product NDC
63187-694
11-digit product format
631870694
Labeler code
63187
Product ID
63187-694_e97313e9-cc69-42ae-8eea-de13af3af4ce
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
25; 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
63187-694-306318706943030 TABLET, FILM COATED in 1 BOTTLE (63187-694-30) 2016-04-01NoNoHistorical
63187-694-606318706946060 TABLET, FILM COATED in 1 BOTTLE (63187-694-60) 2016-04-01NoNoHistorical
63187-694-906318706949090 TABLET, FILM COATED in 1 BOTTLE (63187-694-90) 2016-04-01NoNoHistorical

Related DailyMed Labels

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