Bosentan

Product NDC: 46708-383
11-digit product format: 467080383
Labeler code: 46708
Product ID: 46708-383_e67f1476-1394-4c2c-b03e-a80d0d4da5cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bosentan
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA211461
Marketing category: ANDA
Marketing start: 2020-01-24
Marketing end: 0000-00-00
Substance: BOSENTAN
Active strength: 63 mg/1
Pharmacologic classes: Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	46708-383		D	Discontinued by firm	2026-07-31
excluded package	package	46708-383	46708-383-10	D	Discontinued by firm	2026-07-31
excluded package	package	46708-383	46708-383-60	D	Discontinued by firm	2026-07-31

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211461-001	BOSENTAN	BOSENTAN	62.5MG	TABLET / ORAL			2020-01-23
A211461-002	BOSENTAN	BOSENTAN	125MG	TABLET / ORAL			2020-01-23

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q326023R30	BOSENTAN	157212-55-0	BOSENTAN

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-383-10	46708038310	100 TABLET, FILM COATED in 1 CARTON (46708-383-10)	2020-01-24	0000-00-00	No	No	Current
46708-383-60	46708038360	60 TABLET, FILM COATED in 1 BOTTLE (46708-383-60)	2020-01-24	0000-00-00	No	No	Current