National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2013-05-02
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 04:05:55
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59148-018-71 | EA - Each | 59148-018 | 066a74b8-88d9-4f6c-a896-56110308c8d3 | 1 | 2013-05-02 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59148-018 | 59148-018-71 |
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 |
|---|---|---|---|---|---|---|---|
| N202971-001 | ABILIFY MAINTENA KIT | ARIPIPRAZOLE | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | |
| N202971-002 | ABILIFY MAINTENA KIT | ARIPIPRAZOLE | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | |
| N202971-003 | ABILIFY MAINTENA KIT | ARIPIPRAZOLE | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | |
| N202971-004 | ABILIFY MAINTENA KIT | ARIPIPRAZOLE | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2014-09-29 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202971-001 | 10980803 | 2033-09-24 | U-1632 | 2021-05-19 | |
| N202971-001 | 10980803 | 2033-09-24 | U-543 | 2021-05-19 | |
| N202971-001 | 11154553 | 2033-09-24 | U-1632 | 2021-11-17 | |
| N202971-001 | 11154553 | 2033-09-24 | U-3245 | 2021-11-17 | |
| N202971-001 | 11154553 | 2033-09-24 | U-814 | 2021-11-17 | |
| N202971-001 | 11344547 | 2033-09-24 | U-1632 | 2022-06-24 | |
| N202971-001 | 11344547 | 2033-09-24 | U-3245 | 2022-06-24 | |
| N202971-001 | 11344547 | 2033-09-24 | U-814 | 2022-06-24 | |
| N202971-001 | 11400087 | 2033-09-24 | U-1632 | 2022-08-29 | |
| N202971-001 | 11400087 | 2033-09-24 | U-3245 | 2022-08-29 | |
| N202971-001 | 11400087 | 2033-09-24 | U-814 | 2022-08-29 | |
| N202971-001 | 10525057 | 2034-03-08 | U-1632 | 2020-01-31 | |
| N202971-001 | 10525057 | 2034-03-08 | U-2723 | 2020-01-31 | |
| N202971-001 | 10525057 | 2034-03-08 | U-543 | 2020-01-31 | |
| N202971-001 | 11648347 | 2034-04-06 | Drug product | 2023-06-15 | |
| N202971-001 | 12691056 | 2041-04-01 | U-3245 | 2026-08-26 | |
| N202971-001 | 12691056 | 2041-04-01 | U-814 | 2026-08-26 | |
| N202971-002 | 10980803 | 2033-09-24 | U-1632 | 2021-05-19 | |
| N202971-002 | 10980803 | 2033-09-24 | U-543 | 2021-05-19 | |
| N202971-002 | 11154553 | 2033-09-24 | U-1632 | 2021-11-17 | |
| N202971-002 | 11154553 | 2033-09-24 | U-3245 | 2021-11-17 | |
| N202971-002 | 11154553 | 2033-09-24 | U-814 | 2021-11-17 | |
| N202971-002 | 11344547 | 2033-09-24 | U-1632 | 2022-06-24 | |
| N202971-002 | 11344547 | 2033-09-24 | U-3245 | 2022-06-24 | |
| N202971-002 | 11344547 | 2033-09-24 | U-814 | 2022-06-24 | |
| N202971-002 | 11400087 | 2033-09-24 | U-1632 | 2022-08-29 | |
| N202971-002 | 11400087 | 2033-09-24 | U-3245 | 2022-08-29 | |
| N202971-002 | 11400087 | 2033-09-24 | U-814 | 2022-08-29 | |
| N202971-002 | 10525057 | 2034-03-08 | U-1632 | 2020-01-31 | |
| N202971-002 | 10525057 | 2034-03-08 | U-2723 | 2020-01-31 | |
| N202971-002 | 10525057 | 2034-03-08 | U-543 | 2020-01-31 | |
| N202971-002 | 11648347 | 2034-04-06 | Drug product | 2023-06-15 | |
| N202971-002 | 12691056 | 2041-04-01 | U-3245 | 2026-08-26 | |
| N202971-002 | 12691056 | 2041-04-01 | U-814 | 2026-08-26 | |
| N202971-003 | 10980803 | 2033-09-24 | U-1632 | 2021-05-19 | |
| N202971-003 | 10980803 | 2033-09-24 | U-543 | 2021-05-19 | |
| N202971-003 | 11154553 | 2033-09-24 | U-1632 | 2021-11-17 | |
| N202971-003 | 11154553 | 2033-09-24 | U-3245 | 2021-11-17 | |
| N202971-003 | 11154553 | 2033-09-24 | U-814 | 2021-11-17 | |
| N202971-003 | 11344547 | 2033-09-24 | U-1632 | 2022-06-24 | |
| N202971-003 | 11344547 | 2033-09-24 | U-3245 | 2022-06-24 | |
| N202971-003 | 11344547 | 2033-09-24 | U-814 | 2022-06-24 | |
| N202971-003 | 11400087 | 2033-09-24 | U-1632 | 2022-08-29 | |
| N202971-003 | 11400087 | 2033-09-24 | U-3245 | 2022-08-29 | |
| N202971-003 | 11400087 | 2033-09-24 | U-814 | 2022-08-29 | |
| N202971-003 | 10525057 | 2034-03-08 | U-1632 | 2020-01-31 | |
| N202971-003 | 10525057 | 2034-03-08 | U-2723 | 2020-01-31 | |
| N202971-003 | 10525057 | 2034-03-08 | U-543 | 2020-01-31 | |
| N202971-003 | 11648347 | 2034-04-06 | Drug product | 2023-06-15 | |
| N202971-003 | 12691056 | 2041-04-01 | U-3245 | 2026-08-26 | |
| N202971-003 | 12691056 | 2041-04-01 | U-814 | 2026-08-26 | |
| N202971-004 | 10980803 | 2033-09-24 | U-1632 | 2021-05-19 | |
| N202971-004 | 10980803 | 2033-09-24 | U-543 | 2021-05-19 | |
| N202971-004 | 11154553 | 2033-09-24 | U-1632 | 2021-11-17 | |
| N202971-004 | 11154553 | 2033-09-24 | U-3245 | 2021-11-17 | |
| N202971-004 | 11154553 | 2033-09-24 | U-814 | 2021-11-17 | |
| N202971-004 | 11344547 | 2033-09-24 | U-1632 | 2022-06-24 | |
| N202971-004 | 11344547 | 2033-09-24 | U-3245 | 2022-06-24 | |
| N202971-004 | 11344547 | 2033-09-24 | U-814 | 2022-06-24 | |
| N202971-004 | 11400087 | 2033-09-24 | U-1632 | 2022-08-29 | |
| N202971-004 | 11400087 | 2033-09-24 | U-3245 | 2022-08-29 | |
| N202971-004 | 11400087 | 2033-09-24 | U-814 | 2022-08-29 | |
| N202971-004 | 10525057 | 2034-03-08 | U-1632 | 2020-01-31 | |
| N202971-004 | 10525057 | 2034-03-08 | U-2723 | 2020-01-31 | |
| N202971-004 | 10525057 | 2034-03-08 | U-543 | 2020-01-31 | |
| N202971-004 | 11648347 | 2034-04-06 | Drug product | 2023-06-15 | |
| N202971-004 | 12691056 | 2041-04-01 | U-3245 | 2026-08-26 | |
| N202971-004 | 12691056 | 2041-04-01 | U-814 | 2026-08-26 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2014-09-29 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2014-09-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2014-09-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2014-09-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2014-09-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2014-09-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AP | RLD | 2013-02-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AP | RLD, RS | 2013-02-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AP | RLD | 2013-02-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AP | RLD, RS | 2013-02-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202971-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202971-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202971-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202971-002 | AP | 1 | 2680178bc6a6… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 10980803 | 2033-09-24 | U-543 | 2021-05-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 10980803 | 2033-09-24 | U-1632 | 2021-05-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 11154553 | 2033-09-24 | U-1632 | 2021-11-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 11154553 | 2033-09-24 | U-814 | 2021-11-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 11154553 | 2033-09-24 | U-3245 | 2021-11-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 11344547 | 2033-09-24 | U-1632 | 2022-06-24 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 11344547 | 2033-09-24 | U-3245 | 2022-06-24 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 11344547 | 2033-09-24 | U-814 | 2022-06-24 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 11400087 | 2033-09-24 | U-3245 | 2022-08-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 11400087 | 2033-09-24 | U-814 | 2022-08-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 11400087 | 2033-09-24 | U-1632 | 2022-08-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 10525057 | 2034-03-08 | U-543 | 2020-01-31 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 10525057 | 2034-03-08 | U-1632 | 2020-01-31 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 10525057 | 2034-03-08 | U-2723 | 2020-01-31 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 11648347 | 2034-04-06 | Drug product | 2023-06-15 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 12691056 | 2041-04-01 | U-814 | 2026-08-26 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-001 | 12691056 | 2041-04-01 | U-3245 | 2026-08-26 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 10980803 | 2033-09-24 | U-543 | 2021-05-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 10980803 | 2033-09-24 | U-1632 | 2021-05-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 11154553 | 2033-09-24 | U-1632 | 2021-11-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 11154553 | 2033-09-24 | U-814 | 2021-11-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 11154553 | 2033-09-24 | U-3245 | 2021-11-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 11344547 | 2033-09-24 | U-1632 | 2022-06-24 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 11344547 | 2033-09-24 | U-3245 | 2022-06-24 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 11344547 | 2033-09-24 | U-814 | 2022-06-24 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 11400087 | 2033-09-24 | U-814 | 2022-08-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 11400087 | 2033-09-24 | U-3245 | 2022-08-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 11400087 | 2033-09-24 | U-1632 | 2022-08-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 10525057 | 2034-03-08 | U-2723 | 2020-01-31 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 10525057 | 2034-03-08 | U-1632 | 2020-01-31 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 10525057 | 2034-03-08 | U-543 | 2020-01-31 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 11648347 | 2034-04-06 | Drug product | 2023-06-15 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 12691056 | 2041-04-01 | U-814 | 2026-08-26 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-002 | 12691056 | 2041-04-01 | U-3245 | 2026-08-26 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-003 | 10980803 | 2033-09-24 | U-543 | 2021-05-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-003 | 10980803 | 2033-09-24 | U-1632 | 2021-05-19 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-003 | 11154553 | 2033-09-24 | U-1632 | 2021-11-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-003 | 11154553 | 2033-09-24 | U-814 | 2021-11-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-003 | 11154553 | 2033-09-24 | U-3245 | 2021-11-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N202971-003 | 11344547 | 2033-09-24 | U-1632 | 2022-06-24 | c2088c7a36db… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N202971-001 | I-746 | 2020-07-27 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N202971-002 | I-746 | 2020-07-27 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N202971-003 | I-746 | 2020-07-27 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N202971-004 | I-746 | 2020-07-27 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N202971-001 | I-746 | 2020-07-27 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N202971-002 | I-746 | 2020-07-27 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N202971-003 | I-746 | 2020-07-27 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N202971-004 | I-746 | 2020-07-27 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N202971-001 | I-746 | 2020-07-27 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N202971-002 | I-746 | 2020-07-27 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N202971-003 | I-746 | 2020-07-27 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N202971-004 | I-746 | 2020-07-27 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N202971-001 | I-746 | 2020-07-27 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N202971-002 | I-746 | 2020-07-27 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N202971-003 | I-746 | 2020-07-27 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N202971-004 | I-746 | 2020-07-27 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N202971-001 | I-746 | 2020-07-27 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N202971-002 | I-746 | 2020-07-27 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N202971-003 | I-746 | 2020-07-27 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N202971-004 | I-746 | 2020-07-27 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N202971-001 | I-746 | 2020-07-27 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N202971-002 | I-746 | 2020-07-27 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N202971-003 | I-746 | 2020-07-27 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N202971-004 | I-746 | 2020-07-27 | ea99ee380514… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.