National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2012-07-24
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 01:26:56
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0007-4887-59 | EA - Each | 0007-4887 | 2eeba445-c4e6-48ba-9ec1-1dff9d405e0d | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0007-4887 | 0007-4887-59 |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
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XL | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | |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XL | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | |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XL | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | |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XL | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-06-13 | |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XL | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-10-31 | |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XL | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-04-10 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 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… |
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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.