NDC 70839-325

Tekturna HCT

Aliskiren Hemifumarate And Hydrochlorothiazide

Tekturna HCT is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Noden Pharma Usa, Inc.. The primary component is Aliskiren Hemifumarate; Hydrochlorothiazide.

Product ID70839-325_1859de2b-dd97-4489-999b-c0199c15ddf4
NDC70839-325
Product TypeHuman Prescription Drug
Proprietary NameTekturna HCT
Generic NameAliskiren Hemifumarate And Hydrochlorothiazide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-08-01
Marketing CategoryNDA / NDA
Application NumberNDA022107
Labeler NameNoden Pharma USA, Inc.
Substance NameALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
Active Ingredient Strength300 mg/1; mg/1
Pharm ClassesRenin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70839-325-30

30 TABLET, FILM COATED in 1 BOTTLE (70839-325-30)
Marketing Start Date2017-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70839-325-90 [70839032590]

Tekturna HCT TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022107
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-01
Marketing End Date2017-01-01

NDC 70839-325-30 [70839032530]

Tekturna HCT TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022107
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-01

NDC 70839-325-01 [70839032501]

Tekturna HCT TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022107
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-01
Marketing End Date2017-01-01

Drug Details

Active Ingredients

IngredientStrength
ALISKIREN HEMIFUMARATE300 mg/1

OpenFDA Data

SPL SET ID:8df0ca6a-58cf-41fc-b890-5c7fa5a3792c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1011755
  • 1011750
  • 1011752
  • 1011753
  • 1011710
  • 1011712
  • 1011713
  • 1011715
  • UPC Code
  • 0370839112305
  • 0370839325309
  • 0370839125305
  • 0370839312309
  • Pharmacological Class

    • Renin Inhibitor [EPC]
    • Renin Inhibitors [MoA]
    • Increased Diuresis [PE]
    • Thiazide Diuretic [EPC]
    • Thiazides [CS]

    Medicade Reported Pricing

    70839032530 TEKTURNA HCT 300-25 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Tekturna HCT" or generic name "Aliskiren Hemifumarate And Hydrochlorothiazide"

    NDCBrand NameGeneric Name
    70839-112Tekturna HCTaliskiren hemifumarate and hydrochlorothiazide
    70839-125Tekturna HCTaliskiren hemifumarate and hydrochlorothiazide
    70839-312Tekturna HCTaliskiren hemifumarate and hydrochlorothiazide
    70839-325Tekturna HCTaliskiren hemifumarate and hydrochlorothiazide

    Trademark Results [Tekturna HCT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TEKTURNA HCT
    TEKTURNA HCT
    77052750 3775076 Live/Registered
    NODEN PHARMA DAC
    2006-11-29

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