Tracleer

Product NDC: 66215-103
11-digit product format: 662150103
Labeler code: 66215
Product ID: 66215-103_c5b01aea-c7d8-45d7-8f5f-5fd8733d7085
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bosentan
Dosage form: TABLET, SOLUBLE
Route: ORAL
Labeler: Actelion Pharmaceuticals US, Inc.
Application: NDA209279
Marketing category: NDA
Marketing start: 2017-11-13
Marketing end: 0000-00-00
Substance: BOSENTAN
Active strength: 32 mg/1
Pharmacologic classes: Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66215-103		D	Discontinued by firm		2026-08-17
excluded package	package	66215-103	66215-103-56	D	Discontinued by firm		2026-08-17

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	66215-103		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66215-103	66215-103-56	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66215-103	66215-103-56	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209279-001	TRACLEER	BOSENTAN	32MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2017-09-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N209279-001	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209279-001	8309126	2026-05-15		Drug product	2017-10-03
N209279-001	7959945	2027-12-28		Drug product	2017-10-03

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 2 · 42 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	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2017-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2017-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2017-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2017-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2017-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2017-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N209279-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209279-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209279-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209279-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209279-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209279-001	AB	1	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209279-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`bb7c543d1eb4…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209279-001	ODE-161	2024-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209279-001	ODE-161	2024-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209279-001	ODE-161	2024-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209279-001	ODE-161	2024-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209279-001	ODE-161	2024-09-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209279-001	ODE-161	2024-09-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209279-001	ODE-161	2024-09-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209279-001	ODE-161	2024-09-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209279-001	ODE-161	2024-09-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209279-001	ODE-161	2024-09-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209279-001	ODE-161	2024-09-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209279-001	ODE-161	2024-09-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209279-001	NP	2020-09-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209279-001	ODE-161	2024-09-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209279-001	ODE-161	2024-09-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209279-001	ODE-161	2024-09-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209279-001	ODE-161	2024-09-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209279-001	ODE-161	2024-09-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209279-001	NP	2020-09-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209279-001	ODE-161	2024-09-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209279-001	NP	2020-09-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209279-001	ODE-161	2024-09-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209279-001	NP	2020-09-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209279-001	ODE-161	2024-09-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209279-001	NP	2020-09-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209279-001	ODE-161	2024-09-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209279-001	NP	2020-09-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209279-001	ODE-161	2024-09-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209279-001	ODE-161	2024-09-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209279-001	ODE-161	2024-09-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209279-001	ODE-161	2024-09-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209279-001	ODE-161	2024-09-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209279-001	ODE-161	2024-09-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209279-001	ODE-161	2024-09-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209279-001	ODE-161	2024-09-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209279-001	ODE-161	2024-09-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209279-001	ODE-161	2024-09-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209279-001	ODE-161	2024-09-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209279-001	ODE-161	2024-09-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209279-001	ODE-161	2024-09-05	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66215-103-14	EA - Each	66215-103	054d0ade-11a9-4082-80ef-aa8c4197a47c	1	2017-12-14
66215-103-56	EA - Each	66215-103	4d1809a2-0af0-46fa-8559-bacfcfe9931c	1	2018-01-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
bosentan	ACTIVE INGREDIENT	Q326023R30	TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]	10
bosentan anhydrous	ACTIVE MOIETY	XUL93R30K2	TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]	10
ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]	10
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]	10
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]	10
glyceryl dibehenate	INACTIVE INGREDIENT	R8WTH25YS2	TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]	10
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]	10
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]	10
povidone k90	INACTIVE INGREDIENT	RDH86HJV5Z	TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]	10
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]	10
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]	10
talc	INACTIVE INGREDIENT	7SEV7J4R1U	TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]	10
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]	10
triacetin	INACTIVE INGREDIENT	XHX3C3X673	TRACLEER (BOSENTAN) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66215-103	TRACLEER (BOSENTAN) TABLET, FILM COATED TRACLEER (BOSENTAN) TABLET, FOR SUSPENSION [ACTELION PHARMACEUTICALS US, INC.]	32	Legacy NDC	20240223_749e42fb-2fe0-45dd-9268-b43bb3f4081c.zip

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): 209279 application number: NDA209279

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66215-103-56	66215010356	4 BLISTER PACK in 1 CARTON (66215-103-56) > 14 TABLET, SOLUBLE in 1 BLISTER PACK (66215-103-14)	4 blister pack	2017-11-13	0000-00-00	No	No	Current