NDC 65162-874

Bosentan

Bosentan

Bosentan is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Bosentan Anhydrous.

• Product ID: 65162-874_1fb8b35b-4aa6-4ba0-86c1-9e9d1afe31ea
• NDC: 65162-874
• Product Type: Human Prescription Drug
• Proprietary Name: Bosentan
• Generic Name: Bosentan
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209742
• Labeler Name: Amneal Pharmaceuticals LLC
• Substance Name: BOSENTAN ANHYDROUS
• Active Ingredient Strength: 125 mg/1
• Pharm Classes: Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 65162-874-06

60 TABLET, FILM COATED in 1 BOTTLE (65162-874-06)

• Marketing Start Date: 2019-04-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65162-874-06 [65162087406]

Bosentan TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209742
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-04-26

Drug Details

Active Ingredients

Ingredient	Strength
BOSENTAN ANHYDROUS	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