Home NDC 10148-625-60 bosentan
Product NDC 10148-625
Requested package NDC 10148-625-60
11-digit product format 101480625
Labeler code 10148
Product ID 10148-625_445edd1e-6394-11ea-97fe-c235fc2ca371
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bosentan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CoTherix, Inc.
Application NDA021290
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2019-06-03
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021290-001 TRACLEER BOSENTAN 62.5MG TABLET / ORAL AB RLD 2001-11-20 N021290-002 TRACLEER BOSENTAN 125MG TABLET / ORAL AB RLD, RS 2001-11-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021290-001 TRACLEER 62.5MG TABLET / ORAL AB RLD 2001-11-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021290-002 TRACLEER 125MG TABLET / ORAL AB RLD, RS 2001-11-20 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 66 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tracleer BOSENTAN Actelion Pharmaceuticals US, Inc. 749e42fb-2fe0-45dd-9268-b43bb3f4081c 2025-11-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021290 application number: NDA021290
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 10148-625-60 10148062560 1 BOTTLE, PLASTIC in 1 CARTON (10148-625-60) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2019-06-03 0000-00-00 No No Current