Valsartan and Hydrochlorothiazide

Product NDC
63629-5271
11-digit product format
636295271
Labeler code
63629
Product ID
63629-5271_c3e27e31-e00d-40af-8971-7ad935472f43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202519
Marketing category
ANDA
Marketing start
2013-03-21
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength
13 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
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0J48LPH2THHYDROCHLOROTHIAZIDE58-93-5HYDROCHLOROTHIAZIDE
80M03YXJ7IVALSARTAN137862-53-4VALSARTAN

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-5271-16362952710130 TABLET, FILM COATED in 1 BOTTLE (63629-5271-1) 2015-01-120000-00-00NoNoCurrent
63629-5271-26362952710290 TABLET, FILM COATED in 1 BOTTLE (63629-5271-2) 2014-03-190000-00-00NoNoCurrent