Valsartan and Hydrochlorothiazide

Product NDC
65162-847
11-digit product format
651620847
Labeler code
65162
Product ID
65162-847_e40f4475-c8d3-48a6-913f-cf7c8c7b119b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204382
Marketing category
ANDA
Marketing start
2023-08-14
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
65162-847-036516208470330 TABLET, FILM COATED in 1 BOTTLE (65162-847-03) 2023-08-14NoNoHistorical
65162-847-096516208470990 TABLET, FILM COATED in 1 BOTTLE (65162-847-09) 2023-08-14NoNoHistorical
65162-847-11651620847111000 TABLET, FILM COATED in 1 BOTTLE (65162-847-11) 2023-08-14NoNoHistorical
65162-847-5065162084750500 TABLET, FILM COATED in 1 BOTTLE (65162-847-50) 2023-08-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Valsartan and HydrochlorothiazideAmneal Pharmaceuticals LLC2019-02-02HUMAN PRESCRIPTION DRUG LABEL12