FDA.reportPublic FDA data

Bosentan

Product NDC
62332-383
11-digit product format
623320383
Labeler code
62332
Product ID
62332-383_f958ddae-12bf-4445-b3d5-7787ef601ecc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bosentan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62332-383DDiscontinued by firm2026-07-31
excluded packagepackage62332-38362332-383-10DDiscontinued by firm2026-07-31
excluded packagepackage62332-38362332-383-60DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211461-001BOSENTANBOSENTAN62.5MGTABLET / ORAL2020-01-23
A211461-002BOSENTANBOSENTAN125MGTABLET / ORAL2020-01-23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-383-1062332038310100 TABLET, FILM COATED in 1 CARTON (62332-383-10) 2020-01-240000-00-00NoNoCurrent
62332-383-606233203836060 TABLET, FILM COATED in 1 BOTTLE (62332-383-60) 2020-01-240000-00-00NoNoCurrent