AUSTEDO
- Product NDC
- 68546-181
- 11-digit product format
- 685460181
- Labeler code
- 68546
- Product ID
- 68546-181_0de1abef-824f-4d54-9acf-30aa63d87a5a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- deutetrabenazine
- Dosage form
- KIT
- Labeler
- Teva Neuroscience, Inc.
- Application
- NDA208082
- Marketing category
- NDA
- Marketing start
- 2021-05-06
- Marketing end
- 2023-02-28
- Active strength
- 0
- 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 | 68546-181 | D | Discontinued by firm | 2026-10-21 | ||
| excluded package | package | 68546-181 | 68546-181-49 | D | Discontinued by firm | 2026-10-21 |
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 | 68546-181-49 | 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 | 68546-181-49 | 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 | 68546-181-49 | 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 | 68546-181-49 | 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 | 68546-181-49 | 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 | 68546-181-49 | 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 | 68546-181-49 | 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 | 68546-181-49 | 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 | 68546-181-49 | 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 | 68546-181-49 | 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 | 68546-181-49 | 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 | 68546-181-49 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208082-001 | AUSTEDO | DEUTETRABENAZINE | 6MG | TABLET / ORAL | RLD | 2017-04-03 | |
| N208082-002 | AUSTEDO | DEUTETRABENAZINE | 9MG | TABLET / ORAL | RLD | 2017-04-03 | |
| N208082-003 | AUSTEDO | DEUTETRABENAZINE | 12MG | TABLET / ORAL | RLD, RS | 2017-04-03 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208082-001 | 8524733 | 2031-04-03 | Drug substance, Drug product | 2017-04-04 | |
| N208082-001 | 8524733*PED | 2031-10-03 | Pediatric extension | ||
| N208082-001 | 11666566 | 2033-09-18 | Drug product | 2023-06-16 | |
| N208082-001 | 9233959 | 2033-09-18 | Drug product | 2017-04-04 | |
| N208082-001 | 9296739 | 2033-09-18 | Drug product | 2017-04-04 | |
| N208082-001 | 9550780 | 2033-09-18 | U-1995 | Drug substance, Drug product | 2017-04-04 |
| N208082-001 | 9550780 | 2033-09-18 | U-3055 | Drug substance, Drug product | 2017-04-04 |
| N208082-001 | 9814708 | 2033-09-18 | Drug product | 2017-11-16 | |
| N208082-001 | 11666566*PED | 2034-03-18 | Pediatric extension | ||
| N208082-001 | 9233959*PED | 2034-03-18 | Pediatric extension | ||
| N208082-001 | 9296739*PED | 2034-03-18 | Pediatric extension | ||
| N208082-001 | 9550780*PED | 2034-03-18 | Pediatric extension | ||
| N208082-001 | 9814708*PED | 2034-03-18 | Pediatric extension | ||
| N208082-001 | 10959996 | 2036-03-07 | U-3055 | 2021-03-31 | |
| N208082-001 | 11357772 | 2036-03-07 | U-1995 | 2022-06-27 | |
| N208082-001 | 11357772 | 2036-03-07 | U-3055 | 2022-06-27 | |
| N208082-001 | 11446291 | 2036-03-07 | U-1995 | 2022-10-13 | |
| N208082-001 | 11564917 | 2036-03-07 | U-1995 | 2023-02-15 | |
| N208082-001 | 11648244 | 2036-03-07 | U-1995 | 2023-06-05 | |
| N208082-001 | 12016858 | 2036-03-07 | U-1995 | 2024-07-25 | |
| N208082-001 | 12016858 | 2036-03-07 | U-3055 | 2024-07-25 | |
| N208082-001 | 10959996*PED | 2036-09-07 | Pediatric extension | ||
| N208082-001 | 11357772*PED | 2036-09-07 | Pediatric extension | ||
| N208082-001 | 11446291*PED | 2036-09-07 | Pediatric extension | ||
| N208082-001 | 11564917*PED | 2036-09-07 | Pediatric extension | ||
| N208082-001 | 11648244*PED | 2036-09-07 | Pediatric extension | ||
| N208082-001 | 12016858*PED | 2036-09-07 | Pediatric extension | ||
| N208082-001 | 11179386 | 2038-03-15 | U-1995 | Drug product | 2021-12-02 |
| N208082-001 | 11179386 | 2038-03-15 | U-3055 | Drug product | 2021-12-02 |
| N208082-001 | 11813232 | 2038-03-15 | Drug product | 2023-12-07 | |
| N208082-001 | 11179386*PED | 2038-09-15 | Pediatric extension | ||
| N208082-001 | 11813232*PED | 2038-09-15 | Pediatric extension | ||
| N208082-002 | 8524733 | 2031-04-03 | Drug substance, Drug product | 2017-04-04 | |
| N208082-002 | 8524733*PED | 2031-10-03 | Pediatric extension | ||
| N208082-002 | 11666566 | 2033-09-18 | Drug product | 2023-06-16 | |
| N208082-002 | 9233959 | 2033-09-18 | Drug product | 2017-04-04 | |
| N208082-002 | 9296739 | 2033-09-18 | Drug product | 2017-04-04 | |
| N208082-002 | 9550780 | 2033-09-18 | U-1995 | Drug substance, Drug product | 2017-04-04 |
| N208082-002 | 9550780 | 2033-09-18 | U-3055 | Drug substance, Drug product | 2017-04-04 |
| N208082-002 | 9814708 | 2033-09-18 | Drug product | 2017-11-16 | |
| N208082-002 | 11666566*PED | 2034-03-18 | Pediatric extension | ||
| N208082-002 | 9233959*PED | 2034-03-18 | Pediatric extension | ||
| N208082-002 | 9296739*PED | 2034-03-18 | Pediatric extension | ||
| N208082-002 | 9550780*PED | 2034-03-18 | Pediatric extension | ||
| N208082-002 | 9814708*PED | 2034-03-18 | Pediatric extension | ||
| N208082-002 | 10959996 | 2036-03-07 | U-3055 | 2021-03-31 | |
| N208082-002 | 11357772 | 2036-03-07 | U-1995 | 2022-06-27 | |
| N208082-002 | 11357772 | 2036-03-07 | U-3055 | 2022-06-27 | |
| N208082-002 | 11446291 | 2036-03-07 | U-1995 | 2022-10-13 | |
| N208082-002 | 11564917 | 2036-03-07 | U-1995 | 2023-02-15 | |
| N208082-002 | 11648244 | 2036-03-07 | U-1995 | 2023-06-05 | |
| N208082-002 | 12016858 | 2036-03-07 | U-1995 | 2024-07-25 | |
| N208082-002 | 12016858 | 2036-03-07 | U-3055 | 2024-07-25 | |
| N208082-002 | 10959996*PED | 2036-09-07 | Pediatric extension | ||
| N208082-002 | 11357772*PED | 2036-09-07 | Pediatric extension | ||
| N208082-002 | 11446291*PED | 2036-09-07 | Pediatric extension | ||
| N208082-002 | 11564917*PED | 2036-09-07 | Pediatric extension | ||
| N208082-002 | 11648244*PED | 2036-09-07 | Pediatric extension | ||
| N208082-002 | 12016858*PED | 2036-09-07 | Pediatric extension | ||
| N208082-002 | 11179386 | 2038-03-15 | U-1995 | Drug product | 2021-12-02 |
| N208082-002 | 11179386 | 2038-03-15 | U-3055 | Drug product | 2021-12-02 |
| N208082-002 | 11813232 | 2038-03-15 | Drug product | 2023-12-07 | |
| N208082-002 | 11179386*PED | 2038-09-15 | Pediatric extension | ||
| N208082-002 | 11813232*PED | 2038-09-15 | Pediatric extension | ||
| N208082-003 | 8524733 | 2031-04-03 | Drug substance, Drug product | 2017-04-04 | |
| N208082-003 | 8524733*PED | 2031-10-03 | Pediatric extension | ||
| N208082-003 | 11666566 | 2033-09-18 | Drug product | 2023-06-16 | |
| N208082-003 | 9233959 | 2033-09-18 | Drug product | 2017-04-04 | |
| N208082-003 | 9296739 | 2033-09-18 | Drug product | 2017-04-04 | |
| N208082-003 | 9550780 | 2033-09-18 | U-1995 | Drug substance, Drug product | 2017-04-04 |
| N208082-003 | 9550780 | 2033-09-18 | U-3055 | Drug substance, Drug product | 2017-04-04 |
| N208082-003 | 9814708 | 2033-09-18 | Drug product | 2017-11-16 | |
| N208082-003 | 11666566*PED | 2034-03-18 | Pediatric extension | ||
| N208082-003 | 9233959*PED | 2034-03-18 | Pediatric extension | ||
| N208082-003 | 9296739*PED | 2034-03-18 | Pediatric extension | ||
| N208082-003 | 9550780*PED | 2034-03-18 | Pediatric extension | ||
| N208082-003 | 9814708*PED | 2034-03-18 | Pediatric extension | ||
| N208082-003 | 10959996 | 2036-03-07 | U-3055 | 2021-03-31 | |
| N208082-003 | 11357772 | 2036-03-07 | U-1995 | 2022-06-27 | |
| N208082-003 | 11357772 | 2036-03-07 | U-3055 | 2022-06-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | AUSTEDO | 6MG | TABLET / ORAL | RLD | 2017-04-03 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-002 | AUSTEDO | 9MG | TABLET / ORAL | RLD | 2017-04-03 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-003 | AUSTEDO | 12MG | TABLET / ORAL | RLD, RS | 2017-04-03 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N208082-001 | AUSTEDO | 6MG | TABLET / ORAL | RLD | 2017-04-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208082-002 | AUSTEDO | 9MG | TABLET / ORAL | RLD | 2017-04-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208082-003 | AUSTEDO | 12MG | TABLET / ORAL | RLD, RS | 2017-04-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N208082-001 | AUSTEDO | 6MG | TABLET / ORAL | RLD | 2017-04-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208082-002 | AUSTEDO | 9MG | TABLET / ORAL | RLD | 2017-04-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208082-003 | AUSTEDO | 12MG | TABLET / ORAL | RLD, RS | 2017-04-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208082-001 | AUSTEDO | 6MG | TABLET / ORAL | RLD | 2017-04-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208082-002 | AUSTEDO | 9MG | TABLET / ORAL | RLD | 2017-04-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208082-003 | AUSTEDO | 12MG | TABLET / ORAL | RLD, RS | 2017-04-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208082-001 | AUSTEDO | 6MG | TABLET / ORAL | RLD | 2017-04-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208082-002 | AUSTEDO | 9MG | TABLET / ORAL | RLD | 2017-04-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208082-003 | AUSTEDO | 12MG | TABLET / ORAL | RLD, RS | 2017-04-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208082-001 | AUSTEDO | 6MG | TABLET / ORAL | RLD | 2017-04-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208082-002 | AUSTEDO | 9MG | TABLET / ORAL | RLD | 2017-04-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208082-003 | AUSTEDO | 12MG | TABLET / ORAL | RLD, RS | 2017-04-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208082-001 | AUSTEDO | 6MG | TABLET / ORAL | RLD | 2017-04-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208082-002 | AUSTEDO | 9MG | TABLET / ORAL | RLD | 2017-04-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208082-003 | AUSTEDO | 12MG | TABLET / ORAL | RLD, RS | 2017-04-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208082-001 | AUSTEDO | 6MG | TABLET / ORAL | RLD | 2017-04-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208082-002 | AUSTEDO | 9MG | TABLET / ORAL | RLD | 2017-04-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208082-003 | AUSTEDO | 12MG | TABLET / ORAL | RLD, RS | 2017-04-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208082-001 | AUSTEDO | 6MG | TABLET / ORAL | AB | RLD | 2017-04-03 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208082-002 | AUSTEDO | 9MG | TABLET / ORAL | AB | RLD | 2017-04-03 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208082-003 | AUSTEDO | 12MG | TABLET / ORAL | AB | RLD, RS | 2017-04-03 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208082-001 | AUSTEDO | 6MG | TABLET / ORAL | RLD | 2017-04-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208082-002 | AUSTEDO | 9MG | TABLET / ORAL | RLD | 2017-04-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208082-003 | AUSTEDO | 12MG | TABLET / ORAL | RLD, RS | 2017-04-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208082-001 | AUSTEDO | 6MG | TABLET / ORAL | RLD | 2017-04-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208082-002 | AUSTEDO | 9MG | TABLET / ORAL | RLD | 2017-04-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208082-003 | AUSTEDO | 12MG | TABLET / ORAL | RLD, RS | 2017-04-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208082-001 | AUSTEDO | 6MG | TABLET / ORAL | RLD | 2017-04-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208082-002 | AUSTEDO | 9MG | TABLET / ORAL | RLD | 2017-04-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208082-003 | AUSTEDO | 12MG | TABLET / ORAL | RLD, RS | 2017-04-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208082-001 | AUSTEDO | 6MG | TABLET / ORAL | RLD | 2017-04-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208082-002 | AUSTEDO | 9MG | TABLET / ORAL | RLD | 2017-04-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208082-003 | AUSTEDO | 12MG | TABLET / ORAL | RLD, RS | 2017-04-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208082-001 | AUSTEDO | 6MG | TABLET / ORAL | RLD | 2017-04-03 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208082-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208082-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208082-003 | AB | 1 | 03ed91905a0d… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 8524733 | 2031-04-03 | Drug substance, Drug product | 2017-04-04 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 8524733*PED | 2031-10-03 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11666566 | 2033-09-18 | Drug product | 2023-06-16 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 9233959 | 2033-09-18 | Drug product | 2017-04-04 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 9296739 | 2033-09-18 | Drug product | 2017-04-04 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 9550780 | 2033-09-18 | U-1995 | Drug substance, Drug product | 2017-04-04 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 9550780 | 2033-09-18 | U-3055 | Drug substance, Drug product | 2017-04-04 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 9814708 | 2033-09-18 | Drug product | 2017-11-16 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11666566*PED | 2034-03-18 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 9233959*PED | 2034-03-18 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 9296739*PED | 2034-03-18 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 9550780*PED | 2034-03-18 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 9814708*PED | 2034-03-18 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 10959996 | 2036-03-07 | U-3055 | 2021-03-31 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11357772 | 2036-03-07 | U-1995 | 2022-06-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11357772 | 2036-03-07 | U-3055 | 2022-06-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11446291 | 2036-03-07 | U-1995 | 2022-10-13 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11564917 | 2036-03-07 | U-1995 | 2023-02-15 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11648244 | 2036-03-07 | U-1995 | 2023-06-05 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 12016858 | 2036-03-07 | U-1995 | 2024-07-25 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 12016858 | 2036-03-07 | U-3055 | 2024-07-25 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 10959996*PED | 2036-09-07 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11357772*PED | 2036-09-07 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11446291*PED | 2036-09-07 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11564917*PED | 2036-09-07 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11648244*PED | 2036-09-07 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 12016858*PED | 2036-09-07 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11179386 | 2038-03-15 | U-1995 | Drug product | 2021-12-02 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11179386 | 2038-03-15 | U-3055 | Drug product | 2021-12-02 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11813232 | 2038-03-15 | Drug product | 2023-12-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11179386*PED | 2038-09-15 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N208082-001 | 11813232*PED | 2038-09-15 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N208082-002 | 8524733 | 2031-04-03 | Drug substance, Drug product | 2017-04-04 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-002 | 8524733*PED | 2031-10-03 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N208082-002 | 11666566 | 2033-09-18 | Drug product | 2023-06-16 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-002 | 9233959 | 2033-09-18 | Drug product | 2017-04-04 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-002 | 9296739 | 2033-09-18 | Drug product | 2017-04-04 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N208082-002 | 9550780 | 2033-09-18 | U-1995 | Drug substance, Drug product | 2017-04-04 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208082-002 | 9550780 | 2033-09-18 | U-3055 | Drug substance, Drug product | 2017-04-04 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208082-002 | 9814708 | 2033-09-18 | Drug product | 2017-11-16 | c2088c7a36db… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208082-003 | NCE | 2022-04-03 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208082-003 | PED | 2022-10-03 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208082-003 | ODE-134 | 2024-04-03 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208082-003 | M-54 | 2024-06-24 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208082-003 | PED | 2024-10-03 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208082-003 | PED | 2024-12-24 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-001 | NCE | 2022-04-03 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-001 | PED | 2022-10-03 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-001 | ODE-134 | 2024-04-03 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-001 | M-54 | 2024-06-24 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-001 | PED | 2024-10-03 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-001 | PED | 2024-12-24 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-002 | NCE | 2022-04-03 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-002 | PED | 2022-10-03 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-002 | ODE-134 | 2024-04-03 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-002 | M-54 | 2024-06-24 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-002 | PED | 2024-10-03 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-002 | PED | 2024-12-24 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-003 | NCE | 2022-04-03 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-003 | PED | 2022-10-03 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-003 | ODE-134 | 2024-04-03 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-003 | M-54 | 2024-06-24 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-003 | PED | 2024-10-03 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N208082-003 | PED | 2024-12-24 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-001 | NCE | 2022-04-03 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-001 | PED | 2022-10-03 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-001 | ODE-134 | 2024-04-03 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-001 | M-54 | 2024-06-24 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-001 | PED | 2024-10-03 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-001 | PED | 2024-12-24 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-002 | NCE | 2022-04-03 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-002 | PED | 2022-10-03 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-002 | ODE-134 | 2024-04-03 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-002 | M-54 | 2024-06-24 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-002 | PED | 2024-10-03 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-002 | PED | 2024-12-24 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-003 | NCE | 2022-04-03 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-003 | PED | 2022-10-03 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-003 | ODE-134 | 2024-04-03 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N208082-003 | M-54 | 2024-06-24 | 4b0b4de00fa7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e68dd8a3-5582-4eab-8887-a36647084a78 | Product name | 2 | 20250224 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68546-181-49 | AUSTEDO | 2 in 1 CARTON | KIT | 2 | 35 | |
| 68546-181-49 | AUSTEDO | 1 in 1 BLISTER PACK | KIT | 1 | 35 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68546-181 | AUSTEDO (DEUTETRABENAZINE) TABLET, COATED AUSTEDO (DEUTETRABENAZINE) KIT AUSTEDO XR (DEUTETRABENAZINE) TABLET, FILM COATED, EXTENDED RELEASE [TEVA NEUROSCIENCE, INC.] | 35 | Legacy NDC, 2 package rows | 20250322_7ea3c60a-45c7-44cc-afc2-d87fa53993c0.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2630160 | {14 (24 HR deutetrabenazine 12 MG Extended Release Oral Tablet [Austedo]) / 14 (24 HR deutetrabenazine 24 MG Extended Release Oral Tablet [Austedo]) / 14 (24 HR deutetrabenazine 6 MG Extended Release Oral Tablet [Austedo]) } Pack [Austedo XR Once Daily, 4 Week Titration Pack, 6 MG / 12 MG / 24 MG] | BPCK | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2541519 | {14 (deutetrabenazine 12 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 6 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 9 MG Oral Tablet [Austedo]) } Pack [Austedo 12 MG Starting Dose, 4 Week Titration Pack] | BPCK | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2281115 | {14 (deutetrabenazine 6 MG Oral Tablet [Austedo]) / 14 (deutetrabenazine 9 MG Oral Tablet [Austedo]) } Pack [Austedo 12 MG Starting Dose Pack] | BPCK | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2281117 | {21 (deutetrabenazine 6 MG Oral Tablet [Austedo]) } Pack [Austedo 6 MG Starting Dose Pack] | BPCK | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2686613 | {7 (24 HR deutetrabenazine 12 MG Extended Release Oral Tablet [Austedo]) / 7 (24 HR deutetrabenazine 18 MG Extended Release Oral Tablet [Austedo]) / 7 (24 HR deutetrabenazine 24 MG Extended Release Oral Tablet [Austedo]) / 7 (24 HR deutetrabenazine 30 MG Extended Release Oral Tablet [Austedo]) } Pack [Austedo XR Once Daily, 4 Week Titration Pack, 12 MG / 18 MG / 24 MG / 30 MG] | BPCK | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630159 | {14 (24 HR deutetrabenazine 12 MG Extended Release Oral Tablet) / 14 (24 HR deutetrabenazine 24 MG Extended Release Oral Tablet) / 14 (24 HR deutetrabenazine 6 MG Extended Release Oral Tablet) } Pack | GPCK | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2541520 | {14 (deutetrabenazine 12 MG Oral Tablet) / 21 (deutetrabenazine 6 MG Oral Tablet) / 14 (deutetrabenazine 9 MG Oral Tablet) } Pack | GPCK | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2541518 | {14 (deutetrabenazine 12 MG Oral Tablet) / 28 (deutetrabenazine 6 MG Oral Tablet) / 28 (deutetrabenazine 9 MG Oral Tablet) } Pack | GPCK | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2281114 | {14 (deutetrabenazine 6 MG Oral Tablet) / 14 (deutetrabenazine 9 MG Oral Tablet) } Pack | GPCK | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2281116 | {21 (deutetrabenazine 6 MG Oral Tablet) } Pack | GPCK | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2686612 | {7 (24 HR deutetrabenazine 12 MG Extended Release Oral Tablet) / 7 (24 HR deutetrabenazine 18 MG Extended Release Oral Tablet) / 7 (24 HR deutetrabenazine 24 MG Extended Release Oral Tablet) / 7 (24 HR deutetrabenazine 30 MG Extended Release Oral Tablet) } Pack | GPCK | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2281117 | Austedo (Chorea associated w/Huntington's disease) 6 MG Starting Dose Pack | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 1876916 | Austedo 12 MG Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2541519 | Austedo 12 MG Starting Dose, 4 Week Titration Pack | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 1876920 | Austedo 6 MG Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 1876924 | Austedo 9 MG Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2281115 | Austedo Tardive Dyskinesia 12 MG Starting Dose Pack | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630147 | Austedo XR 12 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2686156 | Austedo XR 18 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630153 | Austedo XR 24 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683285 | Austedo XR 30 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683291 | Austedo XR 36 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683297 | Austedo XR 42 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683303 | Austedo XR 48 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630157 | Austedo XR 6 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2686613 | Austedo XR Once Daily, 4 Week Titration Pack, 12 MG / 18 MG / 24 MG / 30 MG | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630160 | Austedo XR Once Daily, 4 Week Titration Pack, 6 MG / 12 MG / 24 MG | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630144 | deutetrabenazine 12 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 1876910 | deutetrabenazine 12 MG Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2686153 | deutetrabenazine 18 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630150 | deutetrabenazine 24 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683282 | deutetrabenazine 30 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683288 | deutetrabenazine 36 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683300 | deutetrabenazine 48 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630155 | deutetrabenazine 6 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 1876918 | deutetrabenazine 6 MG Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 1876922 | deutetrabenazine 9 MG Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2686612 | deutetrabenazine once daily pack 12 MG (7), 18 MG (7), 24 MG (7), 30 MG (7) Extended Release Oral Tablet 4 Week Pack | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630159 | deutetrabenazine once daily pack 6 MG (14), 12 MG (14), 24 MG (14) Extended Release Oral Tablet 4 Week Pack | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2281114 | deutetrabenazine starter pack 6 MG (14), 9 MG (14) Oral Tablet 2 Week Pack | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2281116 | deutetrabenazine starter pack 6 MG (21) Oral Tablet 2 Week Pack | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2541520 | deutetrabenazine starter pack 6 MG (21), 9 MG (14), 12 MG (14) Oral Tablet 4 Week Pack | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2541518 | deutetrabenazine starter pack 6 MG (28), 9 MG (28), 12 MG (14) Oral Tablet 4 Week Pack | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683294 | deutetrabenazine XR 42 MG 24HR Extended Release Oral Tablet | PSN | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630147 | 24 HR deutetrabenazine 12 MG Extended Release Oral Tablet [Austedo] | SBD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2686156 | 24 HR deutetrabenazine 18 MG Extended Release Oral Tablet [Austedo] | SBD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630153 | 24 HR deutetrabenazine 24 MG Extended Release Oral Tablet [Austedo] | SBD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683285 | 24 HR deutetrabenazine 30 MG Extended Release Oral Tablet [Austedo] | SBD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683291 | 24 HR deutetrabenazine 36 MG Extended Release Oral Tablet [Austedo] | SBD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683297 | 24 HR deutetrabenazine 42 MG Extended Release Oral Tablet [Austedo] | SBD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683303 | 24 HR deutetrabenazine 48 MG Extended Release Oral Tablet [Austedo] | SBD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630157 | 24 HR deutetrabenazine 6 MG Extended Release Oral Tablet [Austedo] | SBD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 1876916 | deutetrabenazine 12 MG Oral Tablet [Austedo] | SBD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 1876920 | deutetrabenazine 6 MG Oral Tablet [Austedo] | SBD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 1876924 | deutetrabenazine 9 MG Oral Tablet [Austedo] | SBD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630144 | 24 HR deutetrabenazine 12 MG Extended Release Oral Tablet | SCD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2686153 | 24 HR deutetrabenazine 18 MG Extended Release Oral Tablet | SCD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630150 | 24 HR deutetrabenazine 24 MG Extended Release Oral Tablet | SCD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683282 | 24 HR deutetrabenazine 30 MG Extended Release Oral Tablet | SCD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683288 | 24 HR deutetrabenazine 36 MG Extended Release Oral Tablet | SCD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683294 | 24 HR deutetrabenazine 42 MG Extended Release Oral Tablet | SCD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683300 | 24 HR deutetrabenazine 48 MG Extended Release Oral Tablet | SCD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630155 | 24 HR deutetrabenazine 6 MG Extended Release Oral Tablet | SCD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 1876910 | deutetrabenazine 12 MG Oral Tablet | SCD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 1876918 | deutetrabenazine 6 MG Oral Tablet | SCD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 1876922 | deutetrabenazine 9 MG Oral Tablet | SCD | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2686156 | 24 HR Austedo 18 MG Extended Release Oral Tablet | SY | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630147 | Austedo 12 MG 24 HR Extended Release Oral Tablet | SY | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 1876916 | Austedo 12 MG Oral Tablet | SY | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2281115 | Austedo 12 MG Starting Dose Pack | SY | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2541519 | Austedo 12 MG Starting Dose, 4 Week Titration Pack | SY | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630153 | Austedo 24 MG 24 HR Extended Release Oral Tablet | SY | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683285 | Austedo 30 MG 24 HR Extended Release Oral Tablet | SY | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683291 | Austedo 36 MG 24 HR Extended Release Oral Tablet | SY | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683297 | Austedo 42 MG 24 HR Extended Release Oral Tablet | SY | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2683303 | Austedo 48 MG 24 HR Extended Release Oral Tablet | SY | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2630157 | Austedo 6 MG 24 HR Extended Release Oral Tablet | SY | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 1876920 | Austedo 6 MG Oral Tablet | SY | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 2281117 | Austedo 6 MG Starting Dose Pack | SY | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
| 1876924 | Austedo 9 MG Oral Tablet | SY | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 | 35 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68546-181-49 | 68546018149 | 2 BLISTER PACK in 1 CARTON (68546-181-49) > 1 KIT in 1 BLISTER PACK | 2 blister pack | 2021-05-06 | 2023-02-28 | Yes | No | Current |