National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2012-07-24
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 02:46:02
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 99207-463-30 | EA - Each | 99207-463 | eb517d66-2dd2-45ff-b201-51c94c6c7d4e | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 99207-463 | 99207-463-30 |
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 |
|---|---|---|---|---|---|---|---|
| N050808-001 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | |
| N050808-002 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | |
| N050808-003 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | |
| N050808-004 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | |
| N050808-005 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | |
| N050808-006 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | |
| N050808-007 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | |
| N050808-008 | SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N050808-001 | 7919483 | 2027-03-07 | U-1078 | ||
| N050808-002 | 7919483 | 2027-03-07 | U-1078 | ||
| N050808-002 | 7541347 | 2027-04-02 | U-917 | ||
| N050808-002 | 7544373 | 2027-04-02 | Drug product | ||
| N050808-003 | 7919483 | 2027-03-07 | U-1078 | ||
| N050808-004 | 7919483 | 2027-03-07 | U-1078 | ||
| N050808-004 | 9192615 | 2031-11-17 | Drug product | 2016-01-08 | |
| N050808-005 | 7919483 | 2027-03-07 | U-1078 | ||
| N050808-005 | 9192615 | 2031-11-17 | Drug product | 2016-01-08 | |
| N050808-006 | 7919483 | 2027-03-07 | U-1078 | ||
| N050808-007 | 7919483 | 2027-03-07 | U-1078 | ||
| N050808-008 | 7919483 | 2027-03-07 | U-1078 |
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 | N050808-001 | SOLODYN | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050808-002 | SOLODYN | EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050808-003 | SOLODYN | EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050808-004 | SOLODYN | EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050808-005 | SOLODYN | EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050808-006 | SOLODYN | EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050808-007 | SOLODYN | EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050808-008 | SOLODYN | EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050808-001 | SOLODYN | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050808-002 | SOLODYN | EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050808-003 | SOLODYN | EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050808-004 | SOLODYN | EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050808-005 | SOLODYN | EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050808-006 | SOLODYN | EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050808-007 | SOLODYN | EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050808-008 | SOLODYN | EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-001 | SOLODYN | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-002 | SOLODYN | EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-003 | SOLODYN | EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-004 | SOLODYN | EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-005 | SOLODYN | EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-006 | SOLODYN | EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-007 | SOLODYN | EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-008 | SOLODYN | EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-001 | SOLODYN | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-002 | SOLODYN | EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-003 | SOLODYN | EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-004 | SOLODYN | EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-005 | SOLODYN | EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-006 | SOLODYN | EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-007 | SOLODYN | EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-008 | SOLODYN | EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-001 | SOLODYN | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-002 | SOLODYN | EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-003 | SOLODYN | EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-004 | SOLODYN | EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-005 | SOLODYN | EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-07-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-006 | SOLODYN | EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-007 | SOLODYN | EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050808-008 | SOLODYN | EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-08-27 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050808-004 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050808-005 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050808-006 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050808-007 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050808-008 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050808-004 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050808-005 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050808-006 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050808-007 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050808-008 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050808-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050808-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050808-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050808-007 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050808-008 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050808-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050808-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050808-006 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050808-007 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050808-008 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050808-004 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050808-005 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050808-006 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050808-007 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050808-008 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050808-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050808-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050808-006 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050808-007 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050808-008 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050808-004 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050808-005 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050808-006 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050808-007 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N050808-008 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050808-004 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N050808-005 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N050808-006 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N050808-007 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N050808-008 | AB | 1 | 782e0a99824c… |
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 | N050808-001 | 7919483 | 2027-03-07 | U-1078 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050808-002 | 7919483 | 2027-03-07 | U-1078 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050808-002 | 7541347 | 2027-04-02 | U-917 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050808-002 | 7544373 | 2027-04-02 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050808-003 | 7919483 | 2027-03-07 | U-1078 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050808-004 | 7919483 | 2027-03-07 | U-1078 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050808-004 | 9192615 | 2031-11-17 | Drug product | 2016-01-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050808-005 | 7919483 | 2027-03-07 | U-1078 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050808-005 | 9192615 | 2031-11-17 | Drug product | 2016-01-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050808-006 | 7919483 | 2027-03-07 | U-1078 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050808-007 | 7919483 | 2027-03-07 | U-1078 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050808-008 | 7919483 | 2027-03-07 | U-1078 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050808-001 | 7919483 | 2027-03-07 | U-1078 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050808-002 | 7919483 | 2027-03-07 | U-1078 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050808-002 | 7541347 | 2027-04-02 | U-917 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050808-002 | 7544373 | 2027-04-02 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050808-003 | 7919483 | 2027-03-07 | U-1078 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050808-004 | 7919483 | 2027-03-07 | U-1078 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050808-004 | 9192615 | 2031-11-17 | Drug product | 2016-01-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050808-005 | 7919483 | 2027-03-07 | U-1078 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050808-005 | 9192615 | 2031-11-17 | Drug product | 2016-01-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050808-006 | 7919483 | 2027-03-07 | U-1078 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050808-007 | 7919483 | 2027-03-07 | U-1078 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050808-008 | 7919483 | 2027-03-07 | U-1078 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-001 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-002 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-002 | 7541347 | 2027-04-02 | U-917 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-002 | 7544373 | 2027-04-02 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-003 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-004 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-004 | 9192615 | 2031-11-17 | Drug product | 2016-01-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-005 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-005 | 9192615 | 2031-11-17 | Drug product | 2016-01-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050808-006 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-007 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050808-008 | 7919483 | 2027-03-07 | U-1078 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-001 | 7790705 | 2025-06-24 | U-1078 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-001 | 8252776 | 2025-06-24 | U-124 | 2012-08-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-001 | 8268804 | 2025-06-24 | U-1078 | 2012-10-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050808-001 | 7919483 | 2027-03-07 | U-1078 | 31067a03dcf5… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.