Diovan HCT

Product NDC
68258-6053
11-digit product format
682586053
Labeler code
68258
Product ID
68258-6053_9dd376a1-3a4f-4e38-ae5a-0f2ae7c310f4
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
Marketing start
1998-03-06
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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00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
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1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
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433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
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f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-6053-3Diovan HCT30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
VALSARTANACTIVE INGREDIENT80M03YXJ7IDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
VALSARTANACTIVE MOIETY80M03YXJ7IDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-6053DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20121011_8a0f0791-16e0-4fe8-941b-a73cc89dbafb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809022Diovan HCT 160 MG / 25 MG Oral TabletPSN8a0f0791-16e0-4fe8-941b-a73cc89dbafb1
349353valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN8a0f0791-16e0-4fe8-941b-a73cc89dbafb1
809022hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [Diovan HCT]SBD8a0f0791-16e0-4fe8-941b-a73cc89dbafb1
349353hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCD8a0f0791-16e0-4fe8-941b-a73cc89dbafb1
809022Diovan HCT 160/25 (valsartan / HCTZ) Oral TabletSY8a0f0791-16e0-4fe8-941b-a73cc89dbafb1
809022Diovan HCT 160/25 Oral TabletSY8a0f0791-16e0-4fe8-941b-a73cc89dbafb1
349353HCTZ 25 MG / valsartan 160 MG Oral TabletSY8a0f0791-16e0-4fe8-941b-a73cc89dbafb1
809022HCTZ 25 MG / valsartan 160 MG Oral Tablet [Diovan HCT]SY8a0f0791-16e0-4fe8-941b-a73cc89dbafb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-6053-36825860530330 in 1 BOTTLEHistorical