NDC 66215-232

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: 66215-232_9fd08026-228f-4cd1-aefe-3a2802958bc6
• NDC: 66215-232
• Product Type: Human Prescription Drug
• Proprietary Name: Tracleer
• Generic Name: Bosentan
• Dosage Form: Tablet, Soluble
• Route of Administration: ORAL
• Marketing Start Date: 2021-07-29
• Marketing Category: 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: 2022-12-31

Packaging

NDC 66215-232-56

4 BLISTER PACK in 1 CARTON (66215-232-56) > 14 TABLET, SOLUBLE in 1 BLISTER PACK (66215-232-14)

• Marketing Start Date: 2021-07-29
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

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