Valsartan and Hydrochlorothiazide

Product NDC
68258-6096
11-digit product format
682586096
Labeler code
68258
Product ID
68258-6096_c2f46e16-af36-41ea-a860-47f23b9612b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
NDA020818
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-09-21
Marketing end
0000-00-00
Substance
VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-6096-3Valsartan and Hydrochlorothiazide30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
68258-6096-9Valsartan and Hydrochlorothiazide90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-6096VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 2 package rows20131107_b8f076d5-f271-4099-8d86-c7b02beece08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200285valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNb8f076d5-f271-4099-8d86-c7b02beece082
349353valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNb8f076d5-f271-4099-8d86-c7b02beece082
200285hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCDb8f076d5-f271-4099-8d86-c7b02beece082
349353hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCDb8f076d5-f271-4099-8d86-c7b02beece082
200285HCTZ 12.5 MG / valsartan 160 MG Oral TabletSYb8f076d5-f271-4099-8d86-c7b02beece082
349353HCTZ 25 MG / valsartan 160 MG Oral TabletSYb8f076d5-f271-4099-8d86-c7b02beece082

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-6096-36825860960330 in 1 BOTTLE, PLASTICHistorical
68258-6096-96825860960990 in 1 BOTTLE, PLASTICHistorical