NDC 46708-384

Bosentan

Bosentan

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

• Product ID: 46708-384_e67f1476-1394-4c2c-b03e-a80d0d4da5cb
• NDC: 46708-384
• Product Type: Human Prescription Drug
• Proprietary Name: Bosentan
• Generic Name: Bosentan
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2020-01-24
• Marketing Category: ANDA / ANDA
• Application Number: ANDA211461
• Labeler Name: Alembic Pharmaceuticals Limited
• 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: 2021-12-31

Packaging

NDC 46708-384-10

100 TABLET, FILM COATED in 1 CARTON (46708-384-10)

• Marketing Start Date: 2020-01-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46708-384-60 [46708038460]

Bosentan TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA211461
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-01-24

NDC 46708-384-10 [46708038410]

Bosentan TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA211461
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-01-24

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