Ambrisentan

Product NDC: 0591-2406
11-digit product format: 005912406
Labeler code: 0591
Product ID: 0591-2406_67758125-7c3e-4b62-8cb3-e17d7f079322
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ambrisentan
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA208252
Marketing category: ANDA
Marketing start: 2019-04-30
Substance: AMBRISENTAN
Active strength: 10 mg/1
Pharmacologic classes: Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	0591-2406		UNFINISHED	Active or certified unfinished drug listing	2026-08-12
unfinished package	package	0591-2406	0591-2406-00	UNFINISHED	Active or certified unfinished drug listing	2026-08-12
unfinished package	package	0591-2406	0591-2406-77	UNFINISHED	Active or certified unfinished drug listing	2026-08-12

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 · 53 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	0591-2406-77	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	0591-2406-00	`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	0591-2406-77	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	0591-2406-00	`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	0591-2406-77	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0591-2406-00	`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	0591-2406-77	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0591-2406-00	`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	0591-2406-77	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0591-2406-00	`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	0591-2406-77	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0591-2406-00	`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	0591-2406-77	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0591-2406-00	`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	0591-2406-77	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0591-2406-00	`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	0591-2406-77	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0591-2406-00	`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	0591-2406-77	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0591-2406-00	`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	0591-2406-77	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	0591-2406-00	`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	0591-2406-00	`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	0591-2406-00	`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	0591-2406-00	`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	0591-2406-00	`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	0591-2406-00	`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	0591-2406-00	`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	0591-2406-00	`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	0591-2406-00	`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	0591-2406-00	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	0591-2406-00	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208252-001	AMBRISENTAN	AMBRISENTAN	5MG	TABLET / ORAL	AB		2019-03-28
A208252-002	AMBRISENTAN	AMBRISENTAN	10MG	TABLET / ORAL	AB		2019-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208252-001	AB
A208252-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208252-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208252-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208252-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208252-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208252-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208252-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208252-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208252-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208252-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208252-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208252-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208252-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208252-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208252-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208252-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208252-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208252-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208252-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208252-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208252-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208252-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208252-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208252-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208252-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208252-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208252-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208252-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208252-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208252-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208252-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208252-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208252-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208252-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208252-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208252-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208252-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208252-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208252-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208252-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208252-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208252-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208252-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ambrisentan
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMBRISENTAN	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HW6NV07QEC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
722116	Internal RxNorm lookup
722122	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
32549c43-f8ff-422c-b42d-ca0877e661cf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
d7db2b61-402f-f2c9-6e9c-10d81037d0ba	Product name	3	20230126
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-2406-30	Ambrisentan	30 in 1 BOTTLE	TABLET, FILM COATED	30		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2406-30	EA - Each	0591-2406	63cb6bd8-9a19-4d1e-912a-4ced2e19ec09	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2406	AMBRISENTAN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	16	Current NDC, Legacy NDC, 1 package rows	20250124_32549c43-f8ff-422c-b42d-ca0877e661cf.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
Ambrisentan	AMBRISENTAN	Actavis Pharma, Inc.	32549c43-f8ff-422c-b42d-ca0877e661cf	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208252 application number: ANDA208252 ndc (product): 0591-2406

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HW6NV07QEC	AMBRISENTAN	177036-94-1	AMBRISENTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
722116	ambrisentan 10 MG Oral Tablet	PSN	32549c43-f8ff-422c-b42d-ca0877e661cf	19
722122	ambrisentan 5 MG Oral Tablet	PSN	32549c43-f8ff-422c-b42d-ca0877e661cf	19
722116	ambrisentan 10 MG Oral Tablet	SCD	32549c43-f8ff-422c-b42d-ca0877e661cf	19
722122	ambrisentan 5 MG Oral Tablet	SCD	32549c43-f8ff-422c-b42d-ca0877e661cf	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2406-00	00591240600	44131 TABLET, FILM COATED in 1 BOX (0591-2406-00)	28-MAR-19				Current
0591-2406-30	00591240630	30 TABLET, FILM COATED in 1 BOTTLE (0591-2406-30)	2019-04-30	0000-00-00	No	No	Current
0591-2406-77	00591240677	52956 TABLET, FILM COATED in 1 CONTAINER (0591-2406-77)	07-AUG-24				Current