Valsartan and Hydrochlorothiazide

Product NDC
53002-1785
11-digit product format
530021785
Labeler code
53002
Product ID
53002-1785_11ffdd65-6c6f-4f6f-b098-4e40f39dc9ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA078946
Marketing category
ANDA
Marketing start
2013-03-21
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength
25 mg/1; mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
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
0J48LPH2THHYDROCHLOROTHIAZIDE58-93-5HYDROCHLOROTHIAZIDE
80M03YXJ7IVALSARTAN137862-53-4VALSARTAN

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1785-35300217850330 TABLET, FILM COATED in 1 BOTTLE (53002-1785-3) 2019-06-010000-00-00NoNoCurrent
53002-1785-95300217850990 TABLET, FILM COATED in 1 BOTTLE (53002-1785-9) 2019-06-010000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Valsartan and HydrochlorothiazideRPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL3