Ambrisentan
- Product NDC
- 49884-353
- 11-digit product format
- 498840353
- Labeler code
- 49884
- Product ID
- 49884-353_3d907352-b0a8-4d87-bb3f-235433818d10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ambrisentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA209509
- Marketing category
- ANDA
- Marketing start
- 2019-04-16
- Marketing end
- 2023-01-31
- Substance
- AMBRISENTAN
- Active strength
- 5 mg/1
- Pharmacologic classes
- Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 49884-353 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 49884-353 | 49884-353-11 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 49884-353 | 49884-353-62 | D | Discontinued by firm | 2026-08-11 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 49884-353-11 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 49884-353-62 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 49884-353-11 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 49884-353-62 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 49884-353-11 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 49884-353-62 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 49884-353-11 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 49884-353-62 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 49884-353-11 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 49884-353-62 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 49884-353-11 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 49884-353-62 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49884-353-11 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49884-353-62 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49884-353-11 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49884-353-62 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49884-353-11 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49884-353-62 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 49884-353-11 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 49884-353-62 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 49884-353-11 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 49884-353-62 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 49884-353-11 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 49884-353-62 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209509-001 | AMBRISENTAN | AMBRISENTAN | 5MG | TABLET / ORAL | 2019-04-10 | ||
| A209509-002 | AMBRISENTAN | AMBRISENTAN | 10MG | TABLET / ORAL | 2019-04-10 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | 2019-04-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | 2019-04-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | 2019-04-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | 2019-04-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | 2019-04-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | 2019-04-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | 2019-04-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | 2019-04-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | 2019-04-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | 2019-04-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | 2019-04-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | 2019-04-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | 2019-04-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | 2019-04-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | 2019-04-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | 2019-04-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | 2019-04-10 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | 2019-04-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | 2019-04-10 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | 2019-04-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | 2019-04-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | 2019-04-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | 2019-04-10 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | 2019-04-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | 2019-04-10 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | 2019-04-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | 2019-04-10 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | 2019-04-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | AB | 2019-04-10 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | AB | 2019-04-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | AB | 2019-04-10 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | AB | 2019-04-10 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | AB | 2019-04-10 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | AB | 2019-04-10 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | AB | 2019-04-10 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | AB | 2019-04-10 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | AB | 2019-04-10 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | AB | 2019-04-10 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A209509-001 | AMBRISENTAN | 5MG | TABLET / ORAL | AB | 2019-04-10 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A209509-002 | AMBRISENTAN | 10MG | TABLET / ORAL | AB | 2019-04-10 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209509-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209509-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A209509-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A209509-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A209509-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A209509-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A209509-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A209509-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A209509-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A209509-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A209509-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A209509-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209509-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209509-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A209509-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A209509-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A209509-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A209509-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A209509-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A209509-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A209509-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A209509-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A209509-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A209509-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A209509-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A209509-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209509-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209509-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A209509-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A209509-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A209509-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A209509-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209509-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209509-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209509-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209509-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209509-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209509-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209509-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209509-002 | AB | 1 | 3f0d92c62455… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49884-353-11 | EA - Each | 49884-353 | 8822078a-67e4-40ab-b87c-00c17fa68b78 | 1 | 2019-05-02 |
| 49884-353-62 | EA - Each | 49884-353 | a1af3c77-89a4-4190-b986-d937ad565a49 | 1 | 2019-05-02 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49884-353-11 | 49884035311 | 30 TABLET, FILM COATED in 1 BOTTLE (49884-353-11) | 2019-04-16 | 2023-01-31 | No | No | Current |
| 49884-353-62 | 49884035362 | 10 TABLET, FILM COATED in 1 BOTTLE (49884-353-62) | 2019-04-16 | 2023-01-31 | No | No | Current |