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 02:46:37
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50458-564-01 | ML - Milliliter | 50458-564 | ecb24c9e-9003-45ce-86ab-ad1bf6ae328f | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50458-564 | 50458-564-01 |
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 |
|---|---|---|---|---|---|---|---|
| N022264-001 | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | |
| N022264-002 | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | |
| N022264-003 | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | |
| N022264-004 | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | |
| N022264-005 | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022264-001 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | |
| N022264-001 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | |
| N022264-002 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | |
| N022264-002 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | |
| N022264-003 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | |
| N022264-003 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | |
| N022264-004 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | |
| N022264-004 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | |
| N022264-005 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | |
| N022264-005 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 |
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 | N022264-001 | INVEGA SUSTENNA | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022264-002 | INVEGA SUSTENNA | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022264-003 | INVEGA SUSTENNA | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022264-004 | INVEGA SUSTENNA | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022264-005 | INVEGA SUSTENNA | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022264-001 | INVEGA SUSTENNA | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022264-002 | INVEGA SUSTENNA | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022264-003 | INVEGA SUSTENNA | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022264-004 | INVEGA SUSTENNA | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022264-005 | INVEGA SUSTENNA | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022264-001 | INVEGA SUSTENNA | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2009-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022264-002 | INVEGA SUSTENNA | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2009-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022264-003 | INVEGA SUSTENNA | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2009-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022264-004 | INVEGA SUSTENNA | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022264-005 | INVEGA SUSTENNA | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2009-07-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022264-001 | INVEGA SUSTENNA | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2009-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022264-002 | INVEGA SUSTENNA | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2009-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022264-003 | INVEGA SUSTENNA | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2009-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022264-004 | INVEGA SUSTENNA | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2009-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022264-005 | INVEGA SUSTENNA | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2009-07-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-001 | INVEGA SUSTENNA | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-002 | INVEGA SUSTENNA | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-003 | INVEGA SUSTENNA | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-004 | INVEGA SUSTENNA | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD, RS | 2009-07-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-005 | INVEGA SUSTENNA | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022264-001 | INVEGA SUSTENNA | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022264-002 | INVEGA SUSTENNA | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022264-003 | INVEGA SUSTENNA | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022264-004 | INVEGA SUSTENNA | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD, RS | 2009-07-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022264-005 | INVEGA SUSTENNA | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022264-001 | INVEGA SUSTENNA | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022264-002 | INVEGA SUSTENNA | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022264-003 | INVEGA SUSTENNA | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022264-004 | INVEGA SUSTENNA | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD, RS | 2009-07-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022264-005 | INVEGA SUSTENNA | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022264-001 | INVEGA SUSTENNA | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022264-002 | INVEGA SUSTENNA | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022264-003 | INVEGA SUSTENNA | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022264-004 | INVEGA SUSTENNA | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD, RS | 2009-07-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022264-005 | INVEGA SUSTENNA | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | N022264-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022264-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022264-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022264-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022264-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022264-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022264-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022264-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022264-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022264-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022264-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022264-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022264-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022264-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022264-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022264-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022264-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022264-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022264-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022264-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022264-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022264-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022264-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022264-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022264-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022264-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022264-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022264-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022264-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022264-004 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022264-005 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022264-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022264-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022264-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022264-004 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022264-005 | AB | 1 | d06236e962d9… |
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 | N022264-001 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022264-001 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022264-002 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022264-002 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022264-003 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022264-003 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022264-004 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022264-004 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022264-005 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022264-005 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022264-001 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022264-001 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022264-002 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022264-002 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022264-003 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022264-003 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022264-004 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022264-004 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022264-005 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022264-005 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022264-001 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022264-001 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022264-002 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022264-002 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022264-003 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022264-003 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022264-004 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022264-004 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022264-005 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022264-005 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022264-001 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022264-001 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022264-002 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022264-002 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022264-003 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022264-003 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022264-004 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022264-004 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022264-005 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022264-005 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 31067a03dcf5… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N022264-001 | M-215 | 2020-12-20 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022264-002 | M-215 | 2020-12-20 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022264-003 | M-215 | 2020-12-20 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022264-004 | M-215 | 2020-12-20 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022264-005 | M-215 | 2020-12-20 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N022264-001 | M-215 | 2020-12-20 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N022264-002 | M-215 | 2020-12-20 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N022264-003 | M-215 | 2020-12-20 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N022264-004 | M-215 | 2020-12-20 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N022264-005 | M-215 | 2020-12-20 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022264-001 | M-215 | 2020-12-20 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N022264-002 | M-215 | 2020-12-20 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N022264-003 | M-215 | 2020-12-20 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N022264-004 | M-215 | 2020-12-20 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N022264-005 | M-215 | 2020-12-20 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022264-001 | M-215 | 2020-12-20 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022264-002 | M-215 | 2020-12-20 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022264-003 | M-215 | 2020-12-20 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022264-004 | M-215 | 2020-12-20 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022264-005 | M-215 | 2020-12-20 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022264-001 | M-215 | 2020-12-20 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022264-002 | M-215 | 2020-12-20 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022264-003 | M-215 | 2020-12-20 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022264-004 | M-215 | 2020-12-20 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022264-005 | M-215 | 2020-12-20 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022264-001 | M-215 | 2020-12-20 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022264-002 | M-215 | 2020-12-20 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022264-003 | M-215 | 2020-12-20 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022264-004 | M-215 | 2020-12-20 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022264-005 | M-215 | 2020-12-20 | ea99ee380514… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| INVEGA SUSTENNA | PALIPERIDONE PALMITATE | Janssen Pharmaceuticals, Inc. | 1af14e42-951d-414d-8564-5d5fce138554 | 2025-02-14 | Boxed warning, Warnings, Adverse reactions | 50458-564-01 50458056401 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.