Valsartan and Hydrochlorothiazide

Product NDC
63187-943
11-digit product format
631870943
Labeler code
63187
Product ID
63187-943_2d51bede-441e-4d75-ab5f-22736967d958
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201662
Marketing category
ANDA
Marketing start
2016-05-20
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
63187-943-306318709433030 TABLET, FILM COATED in 1 BOTTLE (63187-943-30) 2018-01-01NoNoHistorical
63187-943-606318709436060 TABLET, FILM COATED in 1 BOTTLE (63187-943-60) 2018-01-01NoNoHistorical
63187-943-906318709439090 TABLET, FILM COATED in 1 BOTTLE (63187-943-90) 2018-01-01NoNoHistorical

Related DailyMed Labels

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