Valsartan and Hydrochlorothiazide

Product NDC
0781-5952
11-digit product format
007815952
Labeler code
0781
Product ID
0781-5952_ff7a21b8-e6b1-4111-a48f-143877db39eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
NDA020818
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-09-21
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5952-10EA - Each0781-5952ee36ef0e-6939-4dd9-9746-f7d6edbf838212013-02-13
0781-5952-64EA - Each0781-59527f34aa47-7981-45da-8835-8170cd0a5d8212013-02-13
0781-5952-92EA - Each0781-59524cf2f2ad-3327-40bc-b86e-5dcef1772bbe12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5952VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4Legacy NDC20141016_f1a2d5de-3b7f-40c0-a5bd-fd64fac59d7e.zip