NDC 70839-300

Tekturna

Aliskiren Hemifumarate

Tekturna 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.

• Product ID: 70839-300_41dc5660-c40e-42b3-b283-bd315c469048
• NDC: 70839-300
• Product Type: Human Prescription Drug
• Proprietary Name: Tekturna
• Generic Name: Aliskiren Hemifumarate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2007-03-05
• Marketing Category: NDA / NDA
• Application Number: NDA021985
• Labeler Name: Noden Pharma USA, Inc.
• Substance Name: ALISKIREN HEMIFUMARATE
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Renin Inhibitor [EPC],Renin Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 70839-300-30

30 TABLET, FILM COATED in 1 BOTTLE (70839-300-30)

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

NDC SPL Data Element Entries

NDC 70839-300-01 [70839030001]

Tekturna TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021985
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-01-01
• Marketing End Date: 2017-01-01

NDC 70839-300-30 [70839030030]

Tekturna TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021985
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-01-01

NDC 70839-300-99 [70839030099]

Tekturna TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021985
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-12
• Marketing End Date: 2019-05-31

NDC 70839-300-90 [70839030090]

Tekturna TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021985
• 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: 3dd61fa5-1620-4ebf-bbdb-ede29b92fce2
• Manufacturer:
  • Noden Pharma USA, Inc.
• UNII:
  • C8A0P8G029
• RxNorm Concept Unique ID - RxCUI:
  • 1011738
  • 1011739
  • 1011736
  • 1011741
• UPC Code:
  • 0370839150307
  • 0370839300306

Pharmacological Class

• Renin Inhibitor [EPC]
• Renin Inhibitors [MoA]

Medicade Reported Pricing

70839030030 TEKTURNA 300 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Tekturna" or generic name "Aliskiren Hemifumarate"

NDC	Brand Name	Generic Name
50090-1250	Tekturna	aliskiren hemifumarate
50090-2985	Tekturna	aliskiren hemifumarate
70839-150	Tekturna	aliskiren hemifumarate
70839-300	Tekturna	aliskiren hemifumarate
66993-141	Aliskiren	aliskiren hemifumarate
66993-142	Aliskiren	aliskiren hemifumarate