NDC 66215-103

Tracleer

Bosentan

Tracleer is a Oral Tablet, Soluble in the Human Prescription Drug category. It is labeled and distributed by Actelion Pharmaceuticals Us, Inc.. The primary component is Bosentan.

• Product ID: 66215-103_345b005a-6394-11ea-8c7b-1b34fc2ca371
• NDC: 66215-103
• Product Type: Human Prescription Drug
• Proprietary Name: Tracleer
• Generic Name: Bosentan
• Dosage Form: Tablet, Soluble
• Route of Administration: ORAL
• Marketing Start Date: 2017-11-13
• Marketing Category: NDA / NDA
• Application Number: NDA209279
• Labeler Name: Actelion Pharmaceuticals US, Inc.
• Substance Name: BOSENTAN
• Active Ingredient Strength: 32 mg/1
• Pharm Classes: Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 66215-103-56

4 BLISTER PACK in 1 CARTON (66215-103-56) > 14 TABLET, SOLUBLE in 1 BLISTER PACK (66215-103-14)

• Marketing Start Date: 2017-11-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66215-103-56 [66215010356]

Tracleer TABLET, SOLUBLE

• Marketing Category: NDA
• Application Number: NDA209279
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-11-13

NDC 66215-103-14 [66215010314]

Tracleer TABLET, SOLUBLE

• Marketing Category: NDA
• Application Number: NDA209279
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-11-13

Drug Details

Active Ingredients

Ingredient	Strength
BOSENTAN	32 mg/1

OpenFDA Data

• SPL SET ID: 749e42fb-2fe0-45dd-9268-b43bb3f4081c
• Manufacturer:
  • Actelion Pharmaceuticals US, Inc.
• UNII:
  • Q326023R30
• RxNorm Concept Unique ID - RxCUI:
  • 656660
  • 656659
  • 352066
  • 349253
  • 1989085
  • 1989081

Pharmacological Class

• Endothelin Receptor Antagonist [EPC]
• Endothelin Receptor Antagonists [MoA]
• Cytochrome P450 3A Inducers [MoA]
• Cytochrome P450 2C9 Inducers [MoA]

NDC Crossover Matching brand name "Tracleer" or generic name "Bosentan"

NDC	Brand Name	Generic Name
66215-101	Tracleer	bosentan
66215-102	Tracleer	Tracleer
66215-103	Tracleer	Tracleer
0054-0520	Bosentan	Bosentan
0054-0521	Bosentan	Bosentan
0591-2511	bosentan	bosentan
0591-2512	bosentan	bosentan
10148-125	bosentan	bosentan
10148-625	bosentan	bosentan
46708-383	Bosentan	Bosentan
46708-384	Bosentan	Bosentan
47335-038	Bosentan	Bosentan
47335-039	Bosentan	Bosentan
47781-270	Bosentan	Bosentan
47781-271	Bosentan	Bosentan
49884-058	Bosentan	Bosentan
49884-059	Bosentan	Bosentan
62332-383	Bosentan	Bosentan
62332-384	Bosentan	Bosentan
65162-873	Bosentan	Bosentan
65162-874	Bosentan	Bosentan