Valsartan and Hydrochlorothiazide

Product NDC
63629-4805
11-digit product format
636294805
Labeler code
63629
Product ID
63629-4805_1089036d-f39e-4c21-ab63-523046cee88b
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
63629-4805-1636294805011 TABLET, FILM COATED in 1 BOTTLE (63629-4805-1) 2016-02-190000-00-00NoNoCurrent