FDA.reportPublic FDA data

Bosentan

Product NDC
62332-384
Requested package NDC
62332-384-60
11-digit product format
623320384
Labeler code
62332
Product ID
62332-384_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
125 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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62332-38462332-384-60DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A211461-001BOSENTAN62.5MGTABLET / ORAL2020-01-23a50c72e98297…
2026-08-01 22:54:322026-06A211461-002BOSENTAN125MGTABLET / ORAL2020-01-23a50c72e98297…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-384-606233203846060 TABLET, FILM COATED in 1 BOTTLE (62332-384-60) 2020-01-240000-00-00NoNoCurrent