NDC 68258-6053

Diovan HCT

Valsartan And Hydrochlorothiazide

Diovan HCT is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Valsartan; Hydrochlorothiazide.

Product ID68258-6053_9dd376a1-3a4f-4e38-ae5a-0f2ae7c310f4
NDC68258-6053
Product TypeHuman Prescription Drug
Proprietary NameDiovan HCT
Generic NameValsartan And Hydrochlorothiazide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1998-03-06
Marketing CategoryNDA / NDA
Application NumberNDA020818
Labeler NameDispensing Solutions, Inc.
Substance NameVALSARTAN; HYDROCHLOROTHIAZIDE
Active Ingredient Strength160 mg/1; mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68258-6053-3

30 TABLET, FILM COATED in 1 BOTTLE (68258-6053-3)
Marketing Start Date1998-03-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68258-6053-3 [68258605303]

Diovan HCT TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020818
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-03-06
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
VALSARTAN160 mg/1

OpenFDA Data

SPL SET ID:8a0f0791-16e0-4fe8-941b-a73cc89dbafb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 809022
  • 349353
  • Pharmacological Class

    • Angiotensin 2 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]
    • Increased Diuresis [PE]
    • Thiazide Diuretic [EPC]
    • Thiazides [CS]

    NDC Crossover Matching brand name "Diovan HCT" or generic name "Valsartan And Hydrochlorothiazide"

    NDCBrand NameGeneric Name
    0078-0314Diovan HCTvalsartan and hydrochlorothiazide
    0078-0315Diovan HCTvalsartan and hydrochlorothiazide
    0078-0383Diovan HCTvalsartan and hydrochlorothiazide
    0078-0471Diovan HCTvalsartan and hydrochlorothiazide
    0078-0472Diovan HCTvalsartan and hydrochlorothiazide
    68258-6056Diovan HCTDiovan HCT
    68258-6053Diovan HCTDiovan HCT
    68258-6972Diovan HCTDiovan HCT
    68258-6973Diovan HCTDiovan HCT
    55289-820Diovan HCTDiovan HCT
    55289-838Diovan HCTDiovan HCT
    0378-6321Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazide
    0378-6322Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazide
    0378-6323Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazide

    Trademark Results [Diovan HCT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DIOVAN HCT
    DIOVAN HCT
    75189097 2182834 Live/Registered
    NOVARTIS CORPORATION
    1996-10-28

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