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 02:59:05
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0597-0113-17 | EA - Each | 0597-0113 | f28187ca-73fd-43e1-8d35-efb84b84d99d | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0597-0113 | 0597-0113-17 |
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 |
|---|---|---|---|---|---|---|---|
| N022421-001 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | |
| N022421-002 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | |
| N022421-003 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | |
| N022421-004 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | |
| N022421-005 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | |
| N022421-006 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | |
| N022421-007 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022421-001 | 7695734 | 2028-04-26 | Drug product | ||
| N022421-001 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 |
| N022421-002 | 7695734 | 2028-04-26 | Drug product | ||
| N022421-002 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 |
| N022421-003 | 7695734 | 2028-04-26 | Drug product | ||
| N022421-003 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 |
| N022421-004 | 7695734 | 2028-04-26 | Drug product | ||
| N022421-004 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 |
| N022421-005 | 7695734 | 2028-04-26 | Drug product | ||
| N022421-005 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 |
| N022421-006 | 7695734 | 2028-04-26 | Drug product | 2011-06-30 | |
| N022421-006 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 |
| N022421-007 | 7695734 | 2028-04-26 | Drug product | 2011-06-30 | |
| N022421-007 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 |
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 | N022421-001 | MIRAPEX ER | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022421-002 | MIRAPEX ER | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022421-003 | MIRAPEX ER | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022421-004 | MIRAPEX ER | 3MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022421-005 | MIRAPEX ER | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022421-006 | MIRAPEX ER | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022421-007 | MIRAPEX ER | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022421-001 | MIRAPEX ER | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022421-002 | MIRAPEX ER | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022421-003 | MIRAPEX ER | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022421-004 | MIRAPEX ER | 3MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022421-005 | MIRAPEX ER | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022421-006 | MIRAPEX ER | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022421-007 | MIRAPEX ER | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-001 | MIRAPEX ER | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-002 | MIRAPEX ER | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-003 | MIRAPEX ER | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-004 | MIRAPEX ER | 3MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-005 | MIRAPEX ER | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-006 | MIRAPEX ER | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-007 | MIRAPEX ER | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-001 | MIRAPEX ER | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-002 | MIRAPEX ER | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-003 | MIRAPEX ER | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-004 | MIRAPEX ER | 3MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-005 | MIRAPEX ER | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-006 | MIRAPEX ER | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-007 | MIRAPEX ER | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-001 | MIRAPEX ER | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-002 | MIRAPEX ER | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-003 | MIRAPEX ER | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-004 | MIRAPEX ER | 3MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-005 | MIRAPEX ER | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-006 | MIRAPEX ER | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-007 | MIRAPEX ER | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022421-001 | MIRAPEX ER | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022421-002 | MIRAPEX ER | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022421-003 | MIRAPEX ER | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022421-004 | MIRAPEX ER | 3MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022421-005 | MIRAPEX ER | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022421-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022421-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022421-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022421-004 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022421-005 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022421-006 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022421-007 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022421-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022421-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022421-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022421-004 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022421-005 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022421-006 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022421-007 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022421-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022421-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022421-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022421-004 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022421-005 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022421-006 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022421-007 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022421-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022421-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022421-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022421-004 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022421-005 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022421-006 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022421-007 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022421-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022421-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022421-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022421-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022421-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022421-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022421-007 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022421-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022421-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022421-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022421-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022421-005 | AB | 1 | 5d02ea3f76ae… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022421-001 | 7695734 | 2028-04-26 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022421-001 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022421-002 | 7695734 | 2028-04-26 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022421-002 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022421-003 | 7695734 | 2028-04-26 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022421-003 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022421-004 | 7695734 | 2028-04-26 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022421-004 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022421-005 | 7695734 | 2028-04-26 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022421-005 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022421-006 | 7695734 | 2028-04-26 | Drug product | 2011-06-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022421-006 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022421-007 | 7695734 | 2028-04-26 | Drug product | 2011-06-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022421-007 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022421-001 | 7695734 | 2028-04-26 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022421-001 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022421-002 | 7695734 | 2028-04-26 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022421-002 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022421-003 | 7695734 | 2028-04-26 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022421-003 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022421-004 | 7695734 | 2028-04-26 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022421-004 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022421-005 | 7695734 | 2028-04-26 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022421-005 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022421-006 | 7695734 | 2028-04-26 | Drug product | 2011-06-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022421-006 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022421-007 | 7695734 | 2028-04-26 | Drug product | 2011-06-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022421-007 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-001 | 7695734 | 2028-04-26 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022421-001 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-002 | 7695734 | 2028-04-26 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022421-002 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-003 | 7695734 | 2028-04-26 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022421-003 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-004 | 7695734 | 2028-04-26 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022421-004 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-005 | 7695734 | 2028-04-26 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022421-005 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-006 | 7695734 | 2028-04-26 | Drug product | 2011-06-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-006 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 011fe1cb6892… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.