NDC 50090-1250

Tekturna

Aliskiren Hemifumarate

Tekturna is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Aliskiren Hemifumarate.

• Product ID: 50090-1250_ee935dc7-22f5-48a5-9fd9-792b8d1de27f
• NDC: 50090-1250
• 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: A-S Medication Solutions
• 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: 2019-12-31

Packaging

NDC 50090-1250-0

30 TABLET, FILM COATED in 1 BOTTLE (50090-1250-0)

• Marketing Start Date: 2014-11-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-1250-0 [50090125000]

Tekturna TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021985
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-11-28
• Marketing End Date: 2018-03-31

Drug Details

Active Ingredients

Ingredient	Strength
ALISKIREN HEMIFUMARATE	300 mg/1

OpenFDA Data

• SPL SET ID: b7850390-719e-402b-b2cd-3400f83b4030
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • C8A0P8G029
• RxNorm Concept Unique ID - RxCUI:
  • 1011739
  • 1011741

Pharmacological Class

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

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