bosentan

Product NDC: 0591-2512
11-digit product format: 005912512
Labeler code: 0591
Product ID: 0591-2512_8f3d0f83-84b4-4860-9478-c86488f41001
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bosentan
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA207110
Marketing category: ANDA
Marketing start: 2019-06-19
Substance: BOSENTAN
Active strength: 125 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: 2026-12-31
Current FDA listing: Yes

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 · 49 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	0591-2512-77	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	0591-2512-77	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0591-2512-77	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0591-2512-00	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0591-2512-00	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0591-2512-77	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0591-2512-00	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0591-2512-77	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0591-2512-00	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0591-2512-77	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0591-2512-00	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0591-2512-77	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0591-2512-00	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0591-2512-77	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0591-2512-00	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0591-2512-77	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0591-2512-00	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0591-2512-77	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	0591-2512-00	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	0591-2512-77	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	0591-2512-00	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	0591-2512-00	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	0591-2512-00	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	0591-2512-00	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	0591-2512-00	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	0591-2512-00	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	0591-2512-00	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	0591-2512-00	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	0591-2512-00	`263afe128892…`	`91768de4ddbe…`

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
A207110-001	BOSENTAN	BOSENTAN	62.5MG	TABLET / ORAL	AB		2019-04-26
A207110-002	BOSENTAN	BOSENTAN	125MG	TABLET / ORAL	AB		2019-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207110-001	AB
A207110-002	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207110-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207110-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207110-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207110-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207110-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207110-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207110-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207110-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207110-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207110-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207110-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207110-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207110-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207110-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207110-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207110-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207110-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207110-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207110-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207110-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207110-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207110-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207110-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207110-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207110-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207110-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207110-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207110-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207110-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207110-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207110-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207110-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207110-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207110-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207110-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207110-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207110-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207110-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207110-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207110-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207110-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207110-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: bosentan
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BOSENTAN	125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q326023R30	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349253	Internal RxNorm lookup
656659	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
39b2a85f-4322-42d4-b420-1b1d52569143	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d212b88c-a939-e294-be87-fb95301c9fbb	Product name	6	20251118

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-2512-60	bosentan	60 in 1 BOTTLE	TABLET, FILM COATED	60		24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2512-60	EA - Each	0591-2512	6889f118-df4d-4d20-ad0b-06ade10d4ff0	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2512	BOSENTAN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	20	Current NDC, Legacy NDC, 1 package rows	20240423_39b2a85f-4322-42d4-b420-1b1d52569143.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
bosentan	BOSENTAN	Actavis Pharma, Inc.	39b2a85f-4322-42d4-b420-1b1d52569143	2025-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207110 application number: ANDA207110 ndc (product): 0591-2512

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
656659	bosentan 125 MG Oral Tablet	PSN	39b2a85f-4322-42d4-b420-1b1d52569143	24
349253	bosentan 62.5 MG Oral Tablet	PSN	39b2a85f-4322-42d4-b420-1b1d52569143	24
656659	bosentan 125 MG Oral Tablet	SCD	39b2a85f-4322-42d4-b420-1b1d52569143	24
349253	bosentan 62.5 MG Oral Tablet	SCD	39b2a85f-4322-42d4-b420-1b1d52569143	24
656659	bosentan (as bosentan hydrochloride) 125 MG Oral Tablet	SY	39b2a85f-4322-42d4-b420-1b1d52569143	24
349253	bosentan (as bosentan hydrochloride) 62.5 MG Oral Tablet	SY	39b2a85f-4322-42d4-b420-1b1d52569143	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2512-60	00591251260	60 TABLET, FILM COATED in 1 BOTTLE (0591-2512-60)	2019-06-19	0000-00-00	No	No	Current