INVEGA SUSTENNA
- Product NDC
- 50458-561
- 11-digit product format
- 504580561
- Labeler code
- 50458
- Product ID
- 50458-561_2e1c43cb-d27e-b3ac-e063-6394a90ad44a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paliperidone palmitate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- NDA022264
- Marketing category
- NDA
- Marketing start
- 2009-07-31
- Substance
- PALIPERIDONE PALMITATE
- Active strength
- 78 mg/.5mL
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022264-001 | INVEGA SUSTENNA | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022264-002 | INVEGA SUSTENNA | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022264-003 | INVEGA SUSTENNA | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022264-004 | INVEGA SUSTENNA | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD, RS | 2009-07-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022264-005 | INVEGA SUSTENNA | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022264-001 | INVEGA SUSTENNA | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022264-002 | INVEGA SUSTENNA | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022264-003 | INVEGA SUSTENNA | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022264-004 | INVEGA SUSTENNA | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD, RS | 2009-07-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022264-005 | INVEGA SUSTENNA | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | RLD | 2009-07-31 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-001 | 9439906 | 2031-01-26 | U-1901 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-001 | 9439906 | 2031-01-26 | U-543 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-001 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-001 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-002 | 9439906 | 2031-01-26 | U-543 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-002 | 9439906 | 2031-01-26 | U-1901 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-002 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-002 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-003 | 9439906 | 2031-01-26 | U-543 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-003 | 9439906 | 2031-01-26 | U-1901 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-003 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-003 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-004 | 9439906 | 2031-01-26 | U-1901 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-004 | 9439906 | 2031-01-26 | U-543 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-004 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-004 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-005 | 9439906 | 2031-01-26 | U-2758 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-005 | 9439906 | 2031-01-26 | U-2757 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-005 | 9439906 | 2031-01-26 | U-1901 | 2016-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022264-005 | 9439906 | 2031-01-26 | U-543 | 2016-10-11 | 6a471c1ec25d… |
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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- INVEGA SUSTENNA
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PALIPERIDONE PALMITATE | 78 mg/.5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R8P8USM8FR | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 858048 | Internal RxNorm lookup |
| 858051 | Internal RxNorm lookup |
| 858052 | Internal RxNorm lookup |
| 858053 | Internal RxNorm lookup |
| 858054 | Internal RxNorm lookup |
| 858055 | Internal RxNorm lookup |
| 858056 | Internal RxNorm lookup |
| 858057 | Internal RxNorm lookup |
| 858073 | Internal RxNorm lookup |
| 858074 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1af14e42-951d-414d-8564-5d5fce138554 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3752075e-d817-45ea-9aa1-8dc0301cf2aa | Product name | 1 | 20251114 |
| 893dce58-6330-4a9a-ab03-5ffd7148e184 | Product name | 1 | 20250311 |
| b6847380-b533-d626-e29e-10b60b2ad451 | Product name | 9 | 20250303 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| fd328049-536a-4914-b42e-93bf4d93db24 | Product name | 1 | 20220307 |
| 0f0756fc-4d63-4f75-afcc-9c5e62a38d69 | Product name | 2 | 20220304 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50458-561-01 | INVEGA SUSTENNA | 1 in 1 KIT | INJECTION | 1 | 41 | |
| 50458-561-01 | INVEGA SUSTENNA | 0.5 mL in 1 SYRINGE | INJECTION | 0.5 | 41 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50458-561-01 | ML - Milliliter | 50458-561 | ca96170b-70b8-4302-9052-faf12353536d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | 022264 NDA022264 50458-561 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 858057 | Invega Sustenna 117 MG in 0.75 mL Prefilled Syringe | PSN | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858055 | Invega Sustenna 156 MG in 1 ML Prefilled Syringe | PSN | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858053 | Invega Sustenna 234 MG in 1.5 ML Prefilled Syringe | PSN | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858074 | Invega Sustenna 39 MG in 0.25 mL Prefilled Syringe | PSN | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858051 | Invega Sustenna 78 MG in 0.5 mL Prefilled Syringe | PSN | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858056 | paliperidone palmitate 117 MG in 0.75 ML Prefilled Syringe | PSN | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858054 | paliperidone palmitate 156 MG in 1 ML Prefilled Syringe | PSN | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858052 | paliperidone palmitate 234 MG in 1.5 ML Prefilled Syringe | PSN | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858073 | paliperidone palmitate 39 MG in 0.25 ML Prefilled Syringe | PSN | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858048 | paliperidone palmitate 78 MG in 0.5 ML Prefilled Syringe | PSN | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858074 | 0.25 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Invega] | SBD | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858051 | 0.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Invega] | SBD | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858057 | 0.75 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Invega] | SBD | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858055 | 1 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Invega] | SBD | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858053 | 1.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Invega] | SBD | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858073 | 0.25 ML paliperidone palmitate 156 MG/ML Prefilled Syringe | SCD | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858048 | 0.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe | SCD | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858056 | 0.75 ML paliperidone palmitate 156 MG/ML Prefilled Syringe | SCD | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858054 | 1 ML paliperidone palmitate 156 MG/ML Prefilled Syringe | SCD | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858052 | 1.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe | SCD | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858074 | 0.25 ML Invega Sustenna 156 MG/ML Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858051 | 0.5 ML Invega Sustenna 156 MG/ML Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858057 | 0.75 ML Invega Sustenna 156 MG/ML Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858055 | 1 ML Invega Sustenna 156 MG/ML Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858053 | 1.5 ML Invega Sustenna 156 MG/ML Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858057 | Invega Sustenna 117 MG per 0.75 ML Extended Release Injectable Suspension in a Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858057 | Invega Sustenna 117 MG per 0.75 ML Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858055 | Invega Sustenna 156 MG per 1 ML Extended Release Injectable Suspension in a Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858055 | Invega Sustenna 156 MG per 1 ML Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858053 | Invega Sustenna 234 MG per 1.5 ML Extended Release Injectable Suspension in a Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858053 | Invega Sustenna 234 MG per 1.5 ML Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858074 | Invega Sustenna 39 MG per 0.25 ML Extended Release Injectable Suspension in a Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858074 | Invega Sustenna 39 MG per 0.25 ML Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858051 | Invega Sustenna 78 MG per 0.5 ML Extended Release Injectable Suspension in a Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858051 | Invega Sustenna 78 MG per 0.5 ML Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858056 | paliperidone palmitate 117 MG per 0.75 ML Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858054 | paliperidone palmitate 156 MG per 1 ML Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858052 | paliperidone palmitate 234 MG per 1.5 ML Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858073 | paliperidone palmitate 39 MG per 0.25 ML Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
| 858048 | paliperidone palmitate 78 MG per 0.5 ML Prefilled Syringe | SY | 1af14e42-951d-414d-8564-5d5fce138554 | 41 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50458-561-01 | 50458056101 | 1 SYRINGE in 1 KIT (50458-561-01) / .5 mL in 1 SYRINGE | 1 syringe | 2009-07-31 | 0000-00-00 | No | No | Current |