National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2013-02-13
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 03:21:14
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0469-2602-71 | EA - Each | 0469-2602 | b7fa3f72-78e5-46fd-bce8-7f3c6420aeb3 | 1 | 2013-02-13 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0469-2602 | 0469-2602-71 |
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 |
|---|---|---|---|---|---|---|---|
| N202611-001 | MYRBETRIQ | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 |
| N202611-002 | MYRBETRIQ | MIRABEGRON | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N202611-001 | AB |
| N202611-002 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202611-001 | 8772315 | 2028-10-30 | U-2300 | 2018-05-17 | |
| N202611-001 | 8772315*PED | 2029-04-30 | Pediatric extension | ||
| N202611-001 | 10842780 | 2029-09-28 | U-2996 | Drug product | 2020-12-11 |
| N202611-001 | 10842780 | 2029-09-28 | U-3670 | Drug product | 2020-12-11 |
| N202611-001 | 11707451 | 2029-09-28 | U-2996 | 2023-08-21 | |
| N202611-001 | 11707451 | 2029-09-28 | U-3670 | 2023-08-21 | |
| N202611-001 | 12059409 | 2029-09-28 | Drug product | 2024-08-28 | |
| N202611-001 | 12097189 | 2029-09-28 | U-2996 | 2024-10-02 | |
| N202611-001 | 12097189 | 2029-09-28 | U-3670 | 2024-10-02 | |
| N202611-001 | 10842780*PED | 2030-03-28 | Pediatric extension | ||
| N202611-001 | 11707451*PED | 2030-03-28 | Pediatric extension | ||
| N202611-001 | 12059409*PED | 2030-03-28 | Pediatric extension | ||
| N202611-001 | 12097189*PED | 2030-03-28 | Pediatric extension | ||
| N202611-002 | 8772315 | 2028-10-30 | U-2300 | 2018-05-17 | |
| N202611-002 | 8772315*PED | 2029-04-30 | Pediatric extension | ||
| N202611-002 | 10842780 | 2029-09-28 | U-2996 | Drug product | 2020-12-11 |
| N202611-002 | 10842780 | 2029-09-28 | U-3670 | Drug product | 2020-12-11 |
| N202611-002 | 11707451 | 2029-09-28 | U-2996 | 2023-08-21 | |
| N202611-002 | 11707451 | 2029-09-28 | U-3670 | 2023-08-21 | |
| N202611-002 | 12059409 | 2029-09-28 | Drug product | 2024-08-28 | |
| N202611-002 | 12097189 | 2029-09-28 | U-2996 | 2024-10-02 | |
| N202611-002 | 12097189 | 2029-09-28 | U-3670 | 2024-10-02 | |
| N202611-002 | 10842780*PED | 2030-03-28 | Pediatric extension | ||
| N202611-002 | 11707451*PED | 2030-03-28 | Pediatric extension | ||
| N202611-002 | 12059409*PED | 2030-03-28 | Pediatric extension | ||
| N202611-002 | 12097189*PED | 2030-03-28 | Pediatric extension |
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 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N202611-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202611-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202611-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202611-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N202611-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202611-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202611-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202611-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202611-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202611-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-002 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202611-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202611-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N202611-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N202611-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N202611-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N202611-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N202611-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N202611-002 | AB | 1 | a72a2bbeb626… |
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 | N202611-001 | 8772315 | 2028-10-30 | U-2300 | 2018-05-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202611-001 | 8772315*PED | 2029-04-30 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N202611-001 | 10842780 | 2029-09-28 | U-3670 | Drug product | 2020-12-11 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202611-001 | 10842780 | 2029-09-28 | U-2996 | Drug product | 2020-12-11 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202611-001 | 11707451 | 2029-09-28 | U-2996 | 2023-08-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202611-001 | 11707451 | 2029-09-28 | U-3670 | 2023-08-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202611-001 | 12059409 | 2029-09-28 | Drug product | 2024-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202611-001 | 12097189 | 2029-09-28 | U-2996 | 2024-10-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202611-001 | 12097189 | 2029-09-28 | U-3670 | 2024-10-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202611-001 | 10842780*PED | 2030-03-28 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N202611-001 | 11707451*PED | 2030-03-28 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N202611-001 | 12059409*PED | 2030-03-28 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N202611-001 | 12097189*PED | 2030-03-28 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N202611-002 | 8772315 | 2028-10-30 | U-2300 | 2018-05-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202611-002 | 8772315*PED | 2029-04-30 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N202611-002 | 10842780 | 2029-09-28 | U-3670 | Drug product | 2020-12-11 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202611-002 | 10842780 | 2029-09-28 | U-2996 | Drug product | 2020-12-11 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202611-002 | 11707451 | 2029-09-28 | U-2996 | 2023-08-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202611-002 | 11707451 | 2029-09-28 | U-3670 | 2023-08-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202611-002 | 12059409 | 2029-09-28 | Drug product | 2024-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202611-002 | 12097189 | 2029-09-28 | U-2996 | 2024-10-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202611-002 | 12097189 | 2029-09-28 | U-3670 | 2024-10-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202611-002 | 10842780*PED | 2030-03-28 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N202611-002 | 11707451*PED | 2030-03-28 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N202611-002 | 12059409*PED | 2030-03-28 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N202611-002 | 12097189*PED | 2030-03-28 | Pediatric extension | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 8772315 | 2028-10-30 | U-2300 | 2018-05-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 8772315*PED | 2029-04-30 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 10842780 | 2029-09-28 | U-3670 | Drug product | 2020-12-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 10842780 | 2029-09-28 | U-2996 | Drug product | 2020-12-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 11707451 | 2029-09-28 | U-2996 | 2023-08-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 11707451 | 2029-09-28 | U-3670 | 2023-08-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 12059409 | 2029-09-28 | Drug product | 2024-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 12097189 | 2029-09-28 | U-2996 | 2024-10-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 12097189 | 2029-09-28 | U-3670 | 2024-10-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 10842780*PED | 2030-03-28 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 11707451*PED | 2030-03-28 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 12059409*PED | 2030-03-28 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 12097189*PED | 2030-03-28 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | 8772315 | 2028-10-30 | U-2300 | 2018-05-17 | caaa826d4ba7… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-001 | I-855 | 2024-03-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-001 | PED | 2024-09-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-002 | I-855 | 2024-03-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-002 | PED | 2024-09-25 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-001 | I-855 | 2024-03-25 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-001 | PED | 2024-09-25 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-002 | I-855 | 2024-03-25 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-002 | PED | 2024-09-25 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-001 | I-855 | 2024-03-25 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-001 | PED | 2024-09-25 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-002 | I-855 | 2024-03-25 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-002 | PED | 2024-09-25 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-001 | I-855 | 2024-03-25 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-001 | PED | 2024-09-25 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-002 | I-855 | 2024-03-25 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-002 | PED | 2024-09-25 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-001 | I-855 | 2024-03-25 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-001 | PED | 2024-09-25 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-002 | I-855 | 2024-03-25 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-002 | PED | 2024-09-25 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-001 | I-855 | 2024-03-25 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-001 | PED | 2024-09-25 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-002 | I-855 | 2024-03-25 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-002 | PED | 2024-09-25 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-001 | I-855 | 2024-03-25 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-001 | PED | 2024-09-25 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-002 | I-855 | 2024-03-25 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-002 | PED | 2024-09-25 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-001 | I-855 | 2024-03-25 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-001 | PED | 2024-09-25 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-002 | I-855 | 2024-03-25 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-002 | PED | 2024-09-25 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-001 | I-855 | 2024-03-25 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-001 | PED | 2024-09-25 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-002 | I-855 | 2024-03-25 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-002 | PED | 2024-09-25 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202611-001 | I-855 | 2024-03-25 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202611-001 | PED | 2024-09-25 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202611-002 | I-855 | 2024-03-25 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202611-002 | PED | 2024-09-25 | 5c6f7cd8ea54… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.