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 ID: 70839-325_1859de2b-dd97-4489-999b-c0199c15ddf4
• NDC: 70839-325
• Product Type: Human Prescription Drug
• Proprietary Name: Tekturna HCT
• Generic Name: Aliskiren Hemifumarate And Hydrochlorothiazide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2008-08-01
• Marketing Category: NDA / NDA
• Application Number: NDA022107
• Labeler Name: Noden Pharma USA, Inc.
• Substance Name: ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
• Active Ingredient Strength: 300 mg/1; mg/1
• Pharm Classes: Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70839-325-30

30 TABLET, FILM COATED in 1 BOTTLE (70839-325-30)

• Marketing Start Date: 2017-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70839-325-90 [70839032590]

Tekturna HCT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022107
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-01-01
• Marketing End Date: 2017-01-01

NDC 70839-325-30 [70839032530]

Tekturna HCT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022107
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-01-01

NDC 70839-325-01 [70839032501]

Tekturna HCT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022107
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-01-01
• Marketing End Date: 2017-01-01

Drug Details

Active Ingredients

Ingredient	Strength
ALISKIREN HEMIFUMARATE	300 mg/1

OpenFDA Data

• SPL SET ID: 8df0ca6a-58cf-41fc-b890-5c7fa5a3792c
• Manufacturer:
  • Noden Pharma USA, Inc.
• UNII:
  • 0J48LPH2TH
  • C8A0P8G029
• 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"

NDC	Brand Name	Generic Name
70839-112	Tekturna HCT	aliskiren hemifumarate and hydrochlorothiazide
70839-125	Tekturna HCT	aliskiren hemifumarate and hydrochlorothiazide
70839-312	Tekturna HCT	aliskiren hemifumarate and hydrochlorothiazide
70839-325	Tekturna HCT	aliskiren hemifumarate and hydrochlorothiazide