NDC 0078-0314

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 Novartis Pharmaceuticals Corporation. The primary component is Valsartan; Hydrochlorothiazide.

Product ID0078-0314_0fa1a408-909e-4098-96ac-2bef1bd97298
NDC0078-0314
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 NameNovartis Pharmaceuticals Corporation
Substance NameVALSARTAN; HYDROCHLOROTHIAZIDE
Active Ingredient Strength80 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 FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0078-0314-34

90 TABLET, FILM COATED in 1 BOTTLE (0078-0314-34)
Marketing Start Date1998-03-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0314-61 [00078031461]

Diovan HCT TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020818
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-04-06
Marketing End Date2015-08-10

NDC 0078-0314-33 [00078031433]

Diovan HCT TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020818
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-29
Marketing End Date2015-08-10

NDC 0078-0314-34 [00078031434]

Diovan HCT TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020818
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-03-06

NDC 0078-0314-06 [00078031406]

Diovan HCT TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020818
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-03-06
Marketing End Date2015-08-10

Drug Details

Active Ingredients

IngredientStrength
VALSARTAN80 mg/1

OpenFDA Data

SPL SET ID:d76a0419-05ee-437e-884c-65807aea9569
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 809026
  • 809022
  • 636045
  • 636042
  • 809018
  • 809030
  • 809014
  • 200285
  • 200284
  • 349353
    • UPC Code
  • 0300780315340
  • 0300780383349
  • 0300780314343

    • 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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