REQUIP
- Product NDC
- 0007-4887
- 11-digit product format
- 000074887
- Labeler code
- 0007
- Product ID
- 0007-4887_ad111526-a002-4082-8a9a-1cc3b7eddf30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- GlaxoSmithKline LLC
- Application
- NDA022008
- Marketing category
- NDA
- Marketing start
- 2008-06-30
- Marketing end
- 2020-09-30
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
- 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 | 0007-4887 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 0007-4887 | 0007-4887-13 | D | Discontinued by firm | 2026-08-10 |
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 | 0007-4887-13 | 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 | 0007-4887-13 | 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 | 0007-4887-13 | 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 | 0007-4887-13 | 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 | 0007-4887-13 | 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 | 0007-4887-13 | 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 | 0007-4887-13 | 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 | 0007-4887-13 | 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 | 0007-4887-13 | 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 | 0007-4887-13 | 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 | 0007-4887-13 | 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 | 0007-4887-13 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022008-001 | REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | |
| N022008-002 | REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | |
| N022008-003 | REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | |
| N022008-004 | REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | |
| N022008-005 | REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-10-31 | |
| N022008-006 | REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-04-10 |
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 | N022008-001 | REQUIP XL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022008-002 | REQUIP XL | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022008-003 | REQUIP XL | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022008-004 | REQUIP XL | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022008-005 | REQUIP XL | EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022008-006 | REQUIP XL | EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-04-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022008-001 | REQUIP XL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022008-002 | REQUIP XL | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022008-003 | REQUIP XL | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022008-004 | REQUIP XL | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022008-005 | REQUIP XL | EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022008-006 | REQUIP XL | EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-04-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022008-001 | REQUIP XL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022008-002 | REQUIP XL | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022008-003 | REQUIP XL | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022008-004 | REQUIP XL | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022008-005 | REQUIP XL | EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022008-006 | REQUIP XL | EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-04-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022008-001 | REQUIP XL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022008-002 | REQUIP XL | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022008-003 | REQUIP XL | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022008-004 | REQUIP XL | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022008-005 | REQUIP XL | EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022008-006 | REQUIP XL | EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-04-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022008-001 | REQUIP XL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022008-002 | REQUIP XL | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022008-003 | REQUIP XL | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022008-004 | REQUIP XL | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022008-005 | REQUIP XL | EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022008-006 | REQUIP XL | EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-04-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022008-001 | REQUIP XL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022008-002 | REQUIP XL | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022008-003 | REQUIP XL | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022008-004 | REQUIP XL | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022008-005 | REQUIP XL | EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022008-006 | REQUIP XL | EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-04-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022008-001 | REQUIP XL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022008-002 | REQUIP XL | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022008-003 | REQUIP XL | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022008-004 | REQUIP XL | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N022008-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022008-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022008-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022008-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022008-006 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022008-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022008-005 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022008-006 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022008-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N022008-005 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N022008-006 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022008-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N022008-005 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N022008-006 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022008-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N022008-005 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N022008-006 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022008-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022008-004 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022008-005 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022008-006 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022008-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022008-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022008-004 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022008-005 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022008-006 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022008-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022008-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022008-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022008-005 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022008-006 | AB | 1 | ea99ee380514… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N022008-001 | 8303986 | 2021-04-12 | Drug product | 2012-11-26 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022008-001 | 7927624 | 2021-12-02 | U-20 | Drug product | 2011-05-17 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022008-002 | 8303986 | 2021-04-12 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022008-002 | 7927624 | 2021-12-02 | U-20 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022008-003 | 8303986 | 2021-04-12 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022008-003 | 7927624 | 2021-12-02 | U-20 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022008-004 | 8303986 | 2021-04-12 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022008-004 | 7927624 | 2021-12-02 | U-20 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022008-005 | 8303986 | 2021-04-12 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022008-005 | 7927624 | 2021-12-02 | U-20 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022008-006 | 8303986 | 2021-04-12 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022008-006 | 7927624 | 2021-12-02 | U-20 | Drug product | 74a2ff9319b5… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022008-001 | 8303986 | 2021-04-12 | Drug product | 2012-11-26 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022008-001 | 7927624 | 2021-12-02 | U-20 | Drug product | 2011-05-17 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022008-002 | 8303986 | 2021-04-12 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N022008-002 | 7927624 | 2021-12-02 | U-20 | Drug product | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022008-003 | 8303986 | 2021-04-12 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N022008-003 | 7927624 | 2021-12-02 | U-20 | Drug product | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022008-004 | 8303986 | 2021-04-12 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N022008-004 | 7927624 | 2021-12-02 | U-20 | Drug product | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022008-005 | 8303986 | 2021-04-12 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N022008-005 | 7927624 | 2021-12-02 | U-20 | Drug product | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022008-006 | 8303986 | 2021-04-12 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N022008-006 | 7927624 | 2021-12-02 | U-20 | Drug product | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022008-001 | 8303986 | 2021-04-12 | Drug product | 2012-11-26 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022008-001 | 7927624 | 2021-12-02 | U-20 | Drug product | 2011-05-17 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022008-002 | 8303986 | 2021-04-12 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022008-002 | 7927624 | 2021-12-02 | U-20 | Drug product | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022008-003 | 8303986 | 2021-04-12 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022008-003 | 7927624 | 2021-12-02 | U-20 | Drug product | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022008-004 | 8303986 | 2021-04-12 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022008-004 | 7927624 | 2021-12-02 | U-20 | Drug product | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022008-005 | 8303986 | 2021-04-12 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022008-005 | 7927624 | 2021-12-02 | U-20 | Drug product | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022008-006 | 8303986 | 2021-04-12 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022008-006 | 7927624 | 2021-12-02 | U-20 | Drug product | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N022008-001 | 8303986 | 2021-04-12 | Drug product | 2012-11-26 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N022008-001 | 7927624 | 2021-12-02 | U-20 | Drug product | 2011-05-17 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N022008-002 | 8303986 | 2021-04-12 | Drug product | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N022008-002 | 7927624 | 2021-12-02 | U-20 | Drug product | 5aa47cf7b7d7… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N022008-001 | M-203 | 2020-03-23 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022008-002 | M-203 | 2020-03-23 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022008-003 | M-203 | 2020-03-23 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022008-004 | M-203 | 2020-03-23 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022008-005 | M-203 | 2020-03-23 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022008-006 | M-203 | 2020-03-23 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N022008-001 | M-203 | 2020-03-23 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N022008-002 | M-203 | 2020-03-23 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N022008-003 | M-203 | 2020-03-23 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N022008-004 | M-203 | 2020-03-23 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N022008-005 | M-203 | 2020-03-23 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N022008-006 | M-203 | 2020-03-23 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022008-001 | M-203 | 2020-03-23 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N022008-002 | M-203 | 2020-03-23 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N022008-003 | M-203 | 2020-03-23 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N022008-004 | M-203 | 2020-03-23 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N022008-005 | M-203 | 2020-03-23 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N022008-006 | M-203 | 2020-03-23 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022008-001 | M-203 | 2020-03-23 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022008-002 | M-203 | 2020-03-23 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022008-003 | M-203 | 2020-03-23 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022008-004 | M-203 | 2020-03-23 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022008-005 | M-203 | 2020-03-23 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022008-006 | M-203 | 2020-03-23 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022008-001 | M-203 | 2020-03-23 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022008-002 | M-203 | 2020-03-23 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022008-003 | M-203 | 2020-03-23 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022008-004 | M-203 | 2020-03-23 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022008-005 | M-203 | 2020-03-23 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022008-006 | M-203 | 2020-03-23 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022008-001 | M-203 | 2020-03-23 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022008-002 | M-203 | 2020-03-23 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022008-003 | M-203 | 2020-03-23 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022008-004 | M-203 | 2020-03-23 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022008-005 | M-203 | 2020-03-23 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022008-006 | M-203 | 2020-03-23 | ea99ee380514… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0007-4887-13 | EA - Each | 0007-4887 | bd38171b-1877-48e9-9f6f-0371a520f453 | 1 | 2012-07-24 |
| 0007-4887-59 | EA - Each | 0007-4887 | 2eeba445-c4e6-48ba-9ec1-1dff9d405e0d | 1 | 2012-07-24 |