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 01:52:29
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 20482-004-30 | EA - Each | 20482-004 | 5bbb78d7-6cbb-40fb-b552-101dfa0ed437 | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 20482-004 | 20482-004-30 |
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 |
|---|---|---|---|---|---|---|---|
| N202788-001 | SUBSYS | FENTANYL | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | |
| N202788-002 | SUBSYS | FENTANYL | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | |
| N202788-003 | SUBSYS | FENTANYL | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | |
| N202788-004 | SUBSYS | FENTANYL | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | |
| N202788-005 | SUBSYS | FENTANYL | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | |
| N202788-006 | SUBSYS | FENTANYL | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | |
| N202788-007 | SUBSYS | FENTANYL | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202788-001 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-001 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | |
| N202788-001 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | |
| N202788-001 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 |
| N202788-001 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-001 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-001 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-001 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-001 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-001 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-002 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-002 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | |
| N202788-002 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-29 |
| N202788-002 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-002 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-002 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-002 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-002 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-002 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-003 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-003 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | |
| N202788-003 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | |
| N202788-003 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 |
| N202788-003 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-003 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-003 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-003 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-003 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-003 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-004 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-004 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | |
| N202788-004 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | |
| N202788-004 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 |
| N202788-004 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-004 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-004 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-004 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-004 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-004 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-005 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-005 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | |
| N202788-005 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 |
| N202788-005 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-005 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-005 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-005 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-005 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-005 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-006 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-006 | 10610523 | 2027-01-25 | Drug product | 2020-05-06 | |
| N202788-006 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | |
| N202788-006 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 |
| N202788-006 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-006 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-006 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-006 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-006 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-006 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-007 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-007 | 10610523 | 2027-01-25 | Drug product | 2020-05-06 | |
| N202788-007 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | |
| N202788-007 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-29 |
| N202788-007 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-007 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-007 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-007 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-007 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-007 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 |
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 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-006 | SUBSYS | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-007 | SUBSYS | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202788-006 | SUBSYS | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202788-007 | SUBSYS | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-006 | SUBSYS | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-007 | SUBSYS | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-006 | SUBSYS | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-007 | SUBSYS | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-006 | SUBSYS | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-007 | SUBSYS | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | fd3edfee7708… |
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 | N202788-001 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-001 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-001 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-001 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202788-001 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-001 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202788-001 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202788-001 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-001 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-001 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-002 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-002 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-002 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-29 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202788-002 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-002 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202788-002 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202788-002 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-002 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-002 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-003 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-003 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-003 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-003 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202788-003 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-003 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202788-003 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202788-003 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-003 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-003 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-004 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-004 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-004 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-004 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202788-004 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-004 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202788-004 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202788-004 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-004 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-004 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202788-005 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | 84e616aacf4f… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.