NDC 0054-0521

Bosentan

Bosentan

Bosentan is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Bosentan.

• Product ID: 0054-0521_03c560f4-2afd-4b15-9466-cff8a3627610
• NDC: 0054-0521
• Product Type: Human Prescription Drug
• Proprietary Name: Bosentan
• Generic Name: Bosentan
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-06-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208695
• Labeler Name: West-Ward Pharmaceuticals Corp.
• Substance Name: BOSENTAN
• Active Ingredient Strength: 125 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: 2020-12-31

Packaging

NDC 0054-0521-21

60 TABLET in 1 BOTTLE (0054-0521-21)

• Marketing Start Date: 2019-06-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0054-0521-21 [00054052121]

Bosentan TABLET

• Marketing Category: ANDA
• Application Number: ANDA208695
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-04

Drug Details

Active Ingredients

Ingredient	Strength
BOSENTAN	125 mg/1

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 "Bosentan" or generic name "Bosentan"

NDC	Brand Name	Generic Name
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
69097-377	BOSENTAN	BOSENTAN
69097-378	BOSENTAN	BOSENTAN
68382-446	Bosentan	Bosentan
68382-447	Bosentan	Bosentan
70771-1017	Bosentan	Bosentan
70771-1018	Bosentan	Bosentan
68180-387	Bosentan	Bosentan
68180-386	Bosentan	Bosentan
66215-101	Tracleer	bosentan