VALSARTAN AND HYDROCHLOROTHIAZIDE

Product NDC
71335-2633
11-digit product format
713352633
Labeler code
71335
Product ID
71335-2633_6137b669-92d7-4dcc-9965-ac467107f271
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206083
Marketing category
ANDA
Marketing start
2015-10-31
Substance
HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength
25; 160 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
71335-2633-17133526330130 TABLET, FILM COATED in 1 BOTTLE (71335-2633-1) 2025-06-02NoNoHistorical
71335-2633-27133526330290 TABLET, FILM COATED in 1 BOTTLE (71335-2633-2) 2025-06-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
VALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack2025-06-02HUMAN PRESCRIPTION DRUG LABEL1