ZOHYDRO ER
- Product NDC
- 65224-330
- Requested package NDC
- 65224-330-60
- 11-digit product format
- 652240330
- Labeler code
- 65224
- Product ID
- 65224-330_20d675b2-d568-4df4-8502-ccb156b9170e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Persion Pharmaceuticals LLC
- Application
- NDA202880
- Marketing category
- NDA
- Marketing start
- 2013-10-25
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 package | package | 65224-330 | 65224-330-60 | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202880-001 | ZOHYDRO ER | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | |
| N202880-002 | ZOHYDRO ER | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | |
| N202880-003 | ZOHYDRO ER | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | |
| N202880-004 | ZOHYDRO ER | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | |
| N202880-005 | ZOHYDRO ER | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | |
| N202880-006 | ZOHYDRO ER | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202880-001 | 10028946 | 2033-07-25 | U-1810 | 2018-07-27 | |
| N202880-001 | 10322120 | 2033-07-25 | Drug product | 2019-07-17 | |
| N202880-001 | 10456393 | 2033-07-25 | U-1810 | 2019-10-29 | |
| N202880-001 | 10722511 | 2033-07-25 | U-1810 | 2020-08-25 | |
| N202880-001 | 9265760 | 2033-07-25 | U-1810 | 2016-02-23 | |
| N202880-001 | 9326982 | 2033-07-25 | U-1810 | 2016-05-04 | |
| N202880-001 | 9333201 | 2033-07-25 | U-1810 | 2016-05-18 | |
| N202880-001 | 9339499 | 2033-07-25 | U-1810 | 2016-05-18 | |
| N202880-001 | 9421200 | 2033-07-25 | U-1810 | 2016-09-07 | |
| N202880-001 | 9433619 | 2033-07-25 | U-1810 | 2016-09-07 | |
| N202880-001 | 9610286 | 2033-07-25 | U-1810 | 2017-04-05 | |
| N202880-001 | 10092559 | 2034-09-12 | U-55 | 2018-11-13 | |
| N202880-001 | 9132096 | 2034-09-12 | Drug product | 2015-09-22 | |
| N202880-001 | 9452163 | 2034-09-12 | U-55 | 2016-10-11 | |
| N202880-001 | 9486451 | 2034-09-12 | U-55 | 2017-01-12 | |
| N202880-001 | 9713611 | 2034-09-12 | U-55 | Drug product | 2017-08-23 |
| N202880-002 | 10028946 | 2033-07-25 | U-1810 | 2018-07-27 | |
| N202880-002 | 10322120 | 2033-07-25 | Drug product | 2019-07-17 | |
| N202880-002 | 10456393 | 2033-07-25 | U-1810 | 2019-10-29 | |
| N202880-002 | 10722511 | 2033-07-25 | U-1810 | 2020-08-25 | |
| N202880-002 | 9265760 | 2033-07-25 | U-1810 | 2016-02-23 | |
| N202880-002 | 9326982 | 2033-07-25 | U-1810 | 2016-05-04 | |
| N202880-002 | 9333201 | 2033-07-25 | U-1810 | 2016-05-18 | |
| N202880-002 | 9339499 | 2033-07-25 | U-1810 | 2016-05-18 | |
| N202880-002 | 9421200 | 2033-07-25 | U-1810 | 2016-09-07 | |
| N202880-002 | 9433619 | 2033-07-25 | U-1810 | 2016-09-07 | |
| N202880-002 | 9610286 | 2033-07-25 | U-1810 | 2017-04-05 | |
| N202880-002 | 10092559 | 2034-09-12 | U-55 | 2018-11-13 | |
| N202880-002 | 9132096 | 2034-09-12 | Drug product | 2015-09-22 | |
| N202880-002 | 9452163 | 2034-09-12 | U-55 | 2016-10-11 | |
| N202880-002 | 9486451 | 2034-09-12 | U-55 | 2017-01-12 | |
| N202880-002 | 9713611 | 2034-09-12 | U-55 | Drug product | 2017-08-23 |
| N202880-003 | 10028946 | 2033-07-25 | U-1810 | 2018-07-27 | |
| N202880-003 | 10322120 | 2033-07-25 | Drug product | 2019-07-17 | |
| N202880-003 | 10456393 | 2033-07-25 | U-1810 | 2019-10-29 | |
| N202880-003 | 10722511 | 2033-07-25 | U-1810 | 2020-08-25 | |
| N202880-003 | 9265760 | 2033-07-25 | U-1810 | 2016-02-23 | |
| N202880-003 | 9326982 | 2033-07-25 | U-1810 | 2016-05-04 | |
| N202880-003 | 9333201 | 2033-07-25 | U-1810 | 2016-05-18 | |
| N202880-003 | 9339499 | 2033-07-25 | U-1810 | 2016-05-18 | |
| N202880-003 | 9421200 | 2033-07-25 | U-1810 | 2016-09-07 | |
| N202880-003 | 9433619 | 2033-07-25 | U-1810 | 2016-09-07 | |
| N202880-003 | 9610286 | 2033-07-25 | U-1810 | 2017-04-05 | |
| N202880-003 | 10092559 | 2034-09-12 | U-55 | 2018-11-13 | |
| N202880-003 | 9132096 | 2034-09-12 | Drug product | 2015-09-22 | |
| N202880-003 | 9452163 | 2034-09-12 | U-55 | 2016-10-11 | |
| N202880-003 | 9486451 | 2034-09-12 | U-55 | 2017-01-12 | |
| N202880-003 | 9713611 | 2034-09-12 | U-55 | Drug product | 2017-08-23 |
| N202880-004 | 10028946 | 2033-07-25 | U-1810 | 2018-07-27 | |
| N202880-004 | 10322120 | 2033-07-25 | Drug product | 2019-07-17 | |
| N202880-004 | 10456393 | 2033-07-25 | U-1810 | 2019-10-29 | |
| N202880-004 | 10722511 | 2033-07-25 | U-1810 | 2020-08-25 | |
| N202880-004 | 9265760 | 2033-07-25 | U-1810 | 2016-02-23 | |
| N202880-004 | 9326982 | 2033-07-25 | U-1810 | 2016-05-04 | |
| N202880-004 | 9333201 | 2033-07-25 | U-1810 | 2016-05-18 | |
| N202880-004 | 9339499 | 2033-07-25 | U-1810 | 2016-05-18 | |
| N202880-004 | 9421200 | 2033-07-25 | U-1810 | 2016-09-07 | |
| N202880-004 | 9433619 | 2033-07-25 | U-1810 | 2016-09-07 | |
| N202880-004 | 9610286 | 2033-07-25 | U-1810 | 2017-04-05 | |
| N202880-004 | 10092559 | 2034-09-12 | U-55 | 2018-11-13 | |
| N202880-004 | 9132096 | 2034-09-12 | Drug product | 2015-09-22 | |
| N202880-004 | 9452163 | 2034-09-12 | U-55 | 2016-10-11 | |
| N202880-004 | 9486451 | 2034-09-12 | U-55 | 2017-01-12 | |
| N202880-004 | 9713611 | 2034-09-12 | U-55 | Drug product | 2017-08-23 |
| N202880-005 | 10028946 | 2033-07-25 | U-1810 | 2018-07-27 | |
| N202880-005 | 10322120 | 2033-07-25 | Drug product | 2019-07-17 | |
| N202880-005 | 10456393 | 2033-07-25 | U-1810 | 2019-10-29 | |
| N202880-005 | 10722511 | 2033-07-25 | U-1810 | 2020-08-25 | |
| N202880-005 | 9265760 | 2033-07-25 | U-1810 | 2016-02-23 | |
| N202880-005 | 9326982 | 2033-07-25 | U-1810 | 2016-05-04 | |
| N202880-005 | 9333201 | 2033-07-25 | U-1810 | 2016-05-18 | |
| N202880-005 | 9339499 | 2033-07-25 | U-1810 | 2016-05-18 | |
| N202880-005 | 9421200 | 2033-07-25 | U-1810 | 2016-09-07 | |
| N202880-005 | 9433619 | 2033-07-25 | U-1810 | 2016-09-07 | |
| N202880-005 | 9610286 | 2033-07-25 | U-1810 | 2017-04-05 | |
| N202880-005 | 10092559 | 2034-09-12 | U-55 | 2018-11-13 | |
| N202880-005 | 9132096 | 2034-09-12 | Drug product | 2015-09-22 | |
| N202880-005 | 9452163 | 2034-09-12 | U-55 | 2016-10-11 | |
| N202880-005 | 9486451 | 2034-09-12 | U-55 | 2017-01-12 | |
| N202880-005 | 9713611 | 2034-09-12 | U-55 | Drug product | 2017-08-23 |
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 | N202880-001 | ZOHYDRO ER | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | ZOHYDRO ER | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-003 | ZOHYDRO ER | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-004 | ZOHYDRO ER | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-005 | ZOHYDRO ER | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-006 | ZOHYDRO ER | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202880-001 | ZOHYDRO ER | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202880-002 | ZOHYDRO ER | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202880-003 | ZOHYDRO ER | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202880-004 | ZOHYDRO ER | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202880-005 | ZOHYDRO ER | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202880-006 | ZOHYDRO ER | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202880-001 | ZOHYDRO ER | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202880-002 | ZOHYDRO ER | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202880-003 | ZOHYDRO ER | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202880-004 | ZOHYDRO ER | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202880-005 | ZOHYDRO ER | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202880-006 | ZOHYDRO ER | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202880-001 | ZOHYDRO ER | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202880-002 | ZOHYDRO ER | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202880-003 | ZOHYDRO ER | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202880-004 | ZOHYDRO ER | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202880-005 | ZOHYDRO ER | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202880-006 | ZOHYDRO ER | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202880-001 | ZOHYDRO ER | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202880-002 | ZOHYDRO ER | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202880-003 | ZOHYDRO ER | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202880-004 | ZOHYDRO ER | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202880-005 | ZOHYDRO ER | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202880-006 | ZOHYDRO ER | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202880-001 | ZOHYDRO ER | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202880-002 | ZOHYDRO ER | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202880-003 | ZOHYDRO ER | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202880-004 | ZOHYDRO ER | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202880-005 | ZOHYDRO ER | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202880-006 | ZOHYDRO ER | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202880-001 | ZOHYDRO ER | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202880-002 | ZOHYDRO ER | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202880-003 | ZOHYDRO ER | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202880-004 | ZOHYDRO ER | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-10-25 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202880-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202880-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202880-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202880-004 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202880-005 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202880-006 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N202880-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N202880-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N202880-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N202880-004 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N202880-005 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N202880-006 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N202880-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N202880-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N202880-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N202880-004 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N202880-005 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N202880-006 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N202880-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N202880-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N202880-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N202880-004 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N202880-005 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N202880-006 | AB | 1 | c0c555d07b60… |
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 | N202880-001 | 10028946 | 2033-07-25 | U-1810 | 2018-07-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-001 | 10322120 | 2033-07-25 | Drug product | 2019-07-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-001 | 10456393 | 2033-07-25 | U-1810 | 2019-10-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-001 | 10722511 | 2033-07-25 | U-1810 | 2020-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-001 | 9265760 | 2033-07-25 | U-1810 | 2016-02-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-001 | 9326982 | 2033-07-25 | U-1810 | 2016-05-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-001 | 9333201 | 2033-07-25 | U-1810 | 2016-05-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-001 | 9339499 | 2033-07-25 | U-1810 | 2016-05-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-001 | 9421200 | 2033-07-25 | U-1810 | 2016-09-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-001 | 9433619 | 2033-07-25 | U-1810 | 2016-09-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-001 | 9610286 | 2033-07-25 | U-1810 | 2017-04-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-001 | 10092559 | 2034-09-12 | U-55 | 2018-11-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-001 | 9132096 | 2034-09-12 | Drug product | 2015-09-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-001 | 9452163 | 2034-09-12 | U-55 | 2016-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-001 | 9486451 | 2034-09-12 | U-55 | 2017-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-001 | 9713611 | 2034-09-12 | U-55 | Drug product | 2017-08-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 10028946 | 2033-07-25 | U-1810 | 2018-07-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 10322120 | 2033-07-25 | Drug product | 2019-07-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 10456393 | 2033-07-25 | U-1810 | 2019-10-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 10722511 | 2033-07-25 | U-1810 | 2020-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 9265760 | 2033-07-25 | U-1810 | 2016-02-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 9326982 | 2033-07-25 | U-1810 | 2016-05-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 9333201 | 2033-07-25 | U-1810 | 2016-05-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 9339499 | 2033-07-25 | U-1810 | 2016-05-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 9421200 | 2033-07-25 | U-1810 | 2016-09-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 9433619 | 2033-07-25 | U-1810 | 2016-09-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 9610286 | 2033-07-25 | U-1810 | 2017-04-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 10092559 | 2034-09-12 | U-55 | 2018-11-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 9132096 | 2034-09-12 | Drug product | 2015-09-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 9452163 | 2034-09-12 | U-55 | 2016-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 9486451 | 2034-09-12 | U-55 | 2017-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-002 | 9713611 | 2034-09-12 | U-55 | Drug product | 2017-08-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-003 | 10028946 | 2033-07-25 | U-1810 | 2018-07-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-003 | 10322120 | 2033-07-25 | Drug product | 2019-07-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-003 | 10456393 | 2033-07-25 | U-1810 | 2019-10-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-003 | 10722511 | 2033-07-25 | U-1810 | 2020-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-003 | 9265760 | 2033-07-25 | U-1810 | 2016-02-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-003 | 9326982 | 2033-07-25 | U-1810 | 2016-05-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-003 | 9333201 | 2033-07-25 | U-1810 | 2016-05-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202880-003 | 9339499 | 2033-07-25 | U-1810 | 2016-05-18 | 011fe1cb6892… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65224-330-60 | EA - Each | 65224-330 | 93ae7497-051a-4ef6-816e-73b4afdf5b84 | 1 | 2016-02-04 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65224-330-60 | 65224033060 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65224-330-60) | 2013-10-25 | 0000-00-00 | No | No | Current |