Valsartan and Hydrochlorothiazide

Product NDC
63629-6923
11-digit product format
636296923
Labeler code
63629
Product ID
63629-6923_8c106726-6b9a-49e8-9599-ce94ddf8a7eb
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
VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength
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
2021-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-6923-16362969230130 TABLET, FILM COATED in 1 BOTTLE (63629-6923-1) 2016-02-190000-00-00NoNoCurrent
63629-6923-26362969230290 TABLET, FILM COATED in 1 BOTTLE (63629-6923-2) 2016-02-190000-00-00NoNoCurrent