NDC 0078-0563

Exforge HCT

Amlodipine Valsartan And Hydrochlorothiazide

Exforge 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 Amlodipine Besylate; Valsartan; Hydrochlorothiazide.

Product ID0078-0563_10b0a131-e828-48e1-9e2b-92a6bbcb753a
NDC0078-0563
Product TypeHuman Prescription Drug
Proprietary NameExforge HCT
Generic NameAmlodipine Valsartan And Hydrochlorothiazide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-04-04
Marketing CategoryNDA / NDA
Application NumberNDA022314
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameAMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE
Active Ingredient Strength10 mg/1; mg/1; mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0078-0563-15

30 TABLET, FILM COATED in 1 BOTTLE (0078-0563-15)
Marketing Start Date2009-04-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0563-34 [00078056334]

Exforge HCT TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022314
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-04-04
Marketing End Date2014-06-19

NDC 0078-0563-30 [00078056330]

Exforge HCT TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022314
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-04-04
Marketing End Date2019-04-30

NDC 0078-0563-15 [00078056315]

Exforge HCT TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022314
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-04-04

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE10 mg/1

OpenFDA Data

SPL SET ID:18d7820d-471f-4ee2-9ec6-25d8d27c77de
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 848131
  • 848151
  • 848135
  • 848155
  • 848145
  • 848144
  • 848134
  • 848140
  • 848139
  • 848149
  • UPC Code
  • 0300780563154
  • 0300780560153
  • 0300780561150
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0078-0559Exforge HCTamlodipine valsartan and hydrochlorothiazide
    0078-0560Exforge HCTamlodipine valsartan and hydrochlorothiazide
    0078-0561Exforge HCTamlodipine valsartan and hydrochlorothiazide
    0078-0562Exforge HCTamlodipine valsartan and hydrochlorothiazide
    0078-0563Exforge HCTamlodipine valsartan and hydrochlorothiazide
    0781-5756AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine valsartan and hydrochlorothiazide
    0781-5760AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine valsartan and hydrochlorothiazide
    0781-5771AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine valsartan and hydrochlorothiazide
    0781-5787AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine valsartan and hydrochlorothiazide
    0781-5794AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine valsartan and hydrochlorothiazide

    Trademark Results [Exforge HCT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EXFORGE HCT
    EXFORGE HCT
    77202989 3923438 Live/Registered
    Novartis AG
    2007-06-11

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