XTAMPZA
- Product NDC
- 55700-557
- 11-digit product format
- 557000557
- Labeler code
- 55700
- Product ID
- 55700-557_68240be4-abbb-4160-bedb-b057e3da30aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXYCODONE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- NDA208090
- Marketing category
- NDA
- Marketing start
- 2016-05-10
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE
- Active strength
- 14 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 55700-557 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 55700-557 | 55700-557-30 | 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 | 55700-557-30 | 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 | 55700-557-30 | 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 | 55700-557-30 | 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 | 55700-557-30 | 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 | 55700-557-30 | 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 | 55700-557-30 | 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 | 55700-557-30 | 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 | 55700-557-30 | 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 | 55700-557-30 | 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 | 55700-557-30 | 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 | 55700-557-30 | 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 | 55700-557-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208090-001 | XTAMPZA ER | OXYCODONE | 9MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | |
| N208090-002 | XTAMPZA ER | OXYCODONE | 13.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | |
| N208090-003 | XTAMPZA ER | OXYCODONE | 18MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | |
| N208090-004 | XTAMPZA ER | OXYCODONE | 27MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | |
| N208090-005 | XTAMPZA ER | OXYCODONE | 36MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-04-26 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208090-001 | 7771707 | 2028-10-09 | Drug product | 2016-07-19 | |
| N208090-001 | 10004729 | 2030-12-10 | U-1556 | Drug product | 2018-07-10 |
| N208090-001 | 10668060 | 2030-12-10 | U-1556 | Drug product | 2020-06-03 |
| N208090-001 | 9682075 | 2030-12-10 | U-1556 | Drug product | 2017-06-20 |
| N208090-001 | 10188644 | 2036-09-02 | U-1556 | Drug product | 2019-01-29 |
| N208090-001 | 10646485 | 2036-09-02 | U-1556 | Drug product | 2020-05-13 |
| N208090-001 | 9737530 | 2036-09-02 | U-1556 | Drug product | 2017-08-23 |
| N208090-001 | 9968598 | 2036-09-02 | U-1556 | Drug product | 2018-05-16 |
| N208090-002 | 7771707 | 2028-10-09 | Drug product | 2016-07-19 | |
| N208090-002 | 10004729 | 2030-12-10 | U-1556 | Drug product | 2018-07-10 |
| N208090-002 | 10668060 | 2030-12-10 | U-1556 | Drug product | 2020-06-03 |
| N208090-002 | 9682075 | 2030-12-10 | U-1556 | Drug product | 2017-06-20 |
| N208090-002 | 10188644 | 2036-09-02 | U-1556 | Drug product | 2019-01-29 |
| N208090-002 | 10646485 | 2036-09-02 | U-1556 | Drug product | 2020-05-13 |
| N208090-002 | 9737530 | 2036-09-02 | U-1556 | Drug product | 2017-08-23 |
| N208090-002 | 9968598 | 2036-09-02 | U-1556 | Drug product | 2018-05-16 |
| N208090-003 | 7771707 | 2028-10-09 | Drug product | 2016-07-19 | |
| N208090-003 | 10004729 | 2030-12-10 | U-1556 | Drug product | 2018-07-10 |
| N208090-003 | 10668060 | 2030-12-10 | U-1556 | Drug product | 2020-06-03 |
| N208090-003 | 9682075 | 2030-12-10 | U-1556 | Drug product | 2017-06-20 |
| N208090-003 | 10188644 | 2036-09-02 | U-1556 | Drug product | 2019-01-29 |
| N208090-003 | 10646485 | 2036-09-02 | U-1556 | Drug product | 2020-05-13 |
| N208090-003 | 9737530 | 2036-09-02 | U-1556 | Drug product | 2017-08-23 |
| N208090-003 | 9968598 | 2036-09-02 | U-1556 | Drug product | 2018-05-16 |
| N208090-004 | 7771707 | 2028-10-09 | Drug product | 2016-07-19 | |
| N208090-004 | 10004729 | 2030-12-10 | U-1556 | Drug product | 2018-07-10 |
| N208090-004 | 10668060 | 2030-12-10 | U-1556 | Drug product | 2020-06-03 |
| N208090-004 | 9682075 | 2030-12-10 | U-1556 | Drug product | 2017-06-20 |
| N208090-004 | 10188644 | 2036-09-02 | U-1556 | Drug product | 2019-01-29 |
| N208090-004 | 10646485 | 2036-09-02 | U-1556 | Drug product | 2020-05-13 |
| N208090-004 | 9737530 | 2036-09-02 | U-1556 | Drug product | 2017-08-23 |
| N208090-004 | 9968598 | 2036-09-02 | U-1556 | Drug product | 2018-05-16 |
| N208090-005 | 7771707 | 2028-10-09 | Drug product | 2016-07-19 | |
| N208090-005 | 10004729 | 2030-12-10 | U-1556 | Drug product | 2018-07-10 |
| N208090-005 | 10668060 | 2030-12-10 | U-1556 | Drug product | 2020-06-03 |
| N208090-005 | 9682075 | 2030-12-10 | U-1556 | Drug product | 2017-06-20 |
| N208090-005 | 10188644 | 2036-09-02 | U-1556 | Drug product | 2019-01-29 |
| N208090-005 | 10646485 | 2036-09-02 | U-1556 | Drug product | 2020-05-13 |
| N208090-005 | 9737530 | 2036-09-02 | U-1556 | Drug product | 2017-08-23 |
| N208090-005 | 9968598 | 2036-09-02 | U-1556 | Drug product | 2018-05-16 |
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 | N208090-001 | XTAMPZA ER | 9MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-002 | XTAMPZA ER | 13.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-003 | XTAMPZA ER | 18MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-004 | XTAMPZA ER | 27MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-005 | XTAMPZA ER | 36MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-04-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208090-001 | XTAMPZA ER | 9MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208090-002 | XTAMPZA ER | 13.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208090-003 | XTAMPZA ER | 18MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208090-004 | XTAMPZA ER | 27MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208090-005 | XTAMPZA ER | 36MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-04-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208090-001 | XTAMPZA ER | 9MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208090-002 | XTAMPZA ER | 13.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208090-003 | XTAMPZA ER | 18MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208090-004 | XTAMPZA ER | 27MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208090-005 | XTAMPZA ER | 36MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-04-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208090-001 | XTAMPZA ER | 9MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208090-002 | XTAMPZA ER | 13.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208090-003 | XTAMPZA ER | 18MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208090-004 | XTAMPZA ER | 27MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208090-005 | XTAMPZA ER | 36MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-04-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208090-001 | XTAMPZA ER | 9MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208090-002 | XTAMPZA ER | 13.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208090-003 | XTAMPZA ER | 18MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208090-004 | XTAMPZA ER | 27MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208090-005 | XTAMPZA ER | 36MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-04-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208090-001 | XTAMPZA ER | 9MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208090-002 | XTAMPZA ER | 13.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208090-003 | XTAMPZA ER | 18MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208090-004 | XTAMPZA ER | 27MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208090-005 | XTAMPZA ER | 36MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-04-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208090-001 | XTAMPZA ER | 9MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208090-002 | XTAMPZA ER | 13.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208090-003 | XTAMPZA ER | 18MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208090-004 | XTAMPZA ER | 27MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208090-005 | XTAMPZA ER | 36MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-04-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208090-001 | XTAMPZA ER | 9MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208090-002 | XTAMPZA ER | 13.5MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208090-003 | XTAMPZA ER | 18MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208090-004 | XTAMPZA ER | 27MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-04-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208090-005 | XTAMPZA ER | 36MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-04-26 | 5bbf6a4d5a75… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N208090-001 | 7771707 | 2028-10-09 | Drug product | 2016-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-001 | 10004729 | 2030-12-10 | U-1556 | Drug product | 2018-07-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-001 | 10668060 | 2030-12-10 | U-1556 | Drug product | 2020-06-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-001 | 9682075 | 2030-12-10 | U-1556 | Drug product | 2017-06-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-001 | 10188644 | 2036-09-02 | U-1556 | Drug product | 2019-01-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-001 | 10646485 | 2036-09-02 | U-1556 | Drug product | 2020-05-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-001 | 9737530 | 2036-09-02 | U-1556 | Drug product | 2017-08-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-001 | 9968598 | 2036-09-02 | U-1556 | Drug product | 2018-05-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-002 | 7771707 | 2028-10-09 | Drug product | 2016-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-002 | 10004729 | 2030-12-10 | U-1556 | Drug product | 2018-07-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-002 | 10668060 | 2030-12-10 | U-1556 | Drug product | 2020-06-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-002 | 9682075 | 2030-12-10 | U-1556 | Drug product | 2017-06-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-002 | 10188644 | 2036-09-02 | U-1556 | Drug product | 2019-01-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-002 | 10646485 | 2036-09-02 | U-1556 | Drug product | 2020-05-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-002 | 9737530 | 2036-09-02 | U-1556 | Drug product | 2017-08-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-002 | 9968598 | 2036-09-02 | U-1556 | Drug product | 2018-05-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-003 | 7771707 | 2028-10-09 | Drug product | 2016-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-003 | 10004729 | 2030-12-10 | U-1556 | Drug product | 2018-07-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-003 | 10668060 | 2030-12-10 | U-1556 | Drug product | 2020-06-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-003 | 9682075 | 2030-12-10 | U-1556 | Drug product | 2017-06-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-003 | 10188644 | 2036-09-02 | U-1556 | Drug product | 2019-01-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-003 | 10646485 | 2036-09-02 | U-1556 | Drug product | 2020-05-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-003 | 9737530 | 2036-09-02 | U-1556 | Drug product | 2017-08-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-003 | 9968598 | 2036-09-02 | U-1556 | Drug product | 2018-05-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-004 | 7771707 | 2028-10-09 | Drug product | 2016-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-004 | 10004729 | 2030-12-10 | U-1556 | Drug product | 2018-07-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-004 | 10668060 | 2030-12-10 | U-1556 | Drug product | 2020-06-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-004 | 9682075 | 2030-12-10 | U-1556 | Drug product | 2017-06-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-004 | 10188644 | 2036-09-02 | U-1556 | Drug product | 2019-01-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-004 | 10646485 | 2036-09-02 | U-1556 | Drug product | 2020-05-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-004 | 9737530 | 2036-09-02 | U-1556 | Drug product | 2017-08-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-004 | 9968598 | 2036-09-02 | U-1556 | Drug product | 2018-05-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-005 | 7771707 | 2028-10-09 | Drug product | 2016-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-005 | 10004729 | 2030-12-10 | U-1556 | Drug product | 2018-07-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-005 | 10668060 | 2030-12-10 | U-1556 | Drug product | 2020-06-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-005 | 9682075 | 2030-12-10 | U-1556 | Drug product | 2017-06-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-005 | 10188644 | 2036-09-02 | U-1556 | Drug product | 2019-01-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-005 | 10646485 | 2036-09-02 | U-1556 | Drug product | 2020-05-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-005 | 9737530 | 2036-09-02 | U-1556 | Drug product | 2017-08-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208090-005 | 9968598 | 2036-09-02 | U-1556 | Drug product | 2018-05-16 | 011fe1cb6892… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N208090-001 | NP | 2019-04-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N208090-002 | NP | 2019-04-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N208090-003 | NP | 2019-04-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N208090-004 | NP | 2019-04-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N208090-005 | NP | 2019-04-26 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N208090-001 | NP | 2019-04-26 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N208090-002 | NP | 2019-04-26 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N208090-003 | NP | 2019-04-26 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N208090-004 | NP | 2019-04-26 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N208090-005 | NP | 2019-04-26 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N208090-001 | NP | 2019-04-26 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N208090-002 | NP | 2019-04-26 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N208090-003 | NP | 2019-04-26 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N208090-004 | NP | 2019-04-26 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N208090-005 | NP | 2019-04-26 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N208090-001 | NP | 2019-04-26 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N208090-002 | NP | 2019-04-26 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N208090-003 | NP | 2019-04-26 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N208090-004 | NP | 2019-04-26 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N208090-005 | NP | 2019-04-26 | ea99ee380514… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-557-30 | EA - Each | 55700-557 | ba9cfad2-bc9f-4a58-a6ff-c0b968b7a00d | 1 | 2017-11-06 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| XTAMPZA ER | OXYCODONE | Collegium Pharmaceutical, Inc. | b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | 208090 NDA208090 |