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 04:07:43
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0078-0626-51 | EA - Each | 0078-0626 | 8effc4f5-cbc3-46b5-aadf-1e40e4d1cb3b | 1 | 2013-05-02 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0078-0626 | 0078-0626-51 |
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 |
|---|---|---|---|---|---|---|---|
| N203985-001 | AFINITOR DISPERZ | EVEROLIMUS | 2MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 |
| N203985-002 | AFINITOR DISPERZ | EVEROLIMUS | 3MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 |
| N203985-003 | AFINITOR DISPERZ | EVEROLIMUS | 5MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD, RS | 2012-08-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N203985-001 | AB |
| N203985-002 | AB |
| N203985-003 | AB |
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 | N203985-001 | AFINITOR DISPERZ | 2MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N203985-002 | AFINITOR DISPERZ | 3MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N203985-003 | AFINITOR DISPERZ | 5MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD, RS | 2012-08-29 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N203985-001 | AFINITOR DISPERZ | 2MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203985-002 | AFINITOR DISPERZ | 3MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203985-003 | AFINITOR DISPERZ | 5MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD, RS | 2012-08-29 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N203985-001 | AFINITOR DISPERZ | 2MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N203985-002 | AFINITOR DISPERZ | 3MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N203985-003 | AFINITOR DISPERZ | 5MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD, RS | 2012-08-29 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203985-001 | AFINITOR DISPERZ | 2MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203985-002 | AFINITOR DISPERZ | 3MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203985-003 | AFINITOR DISPERZ | 5MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD, RS | 2012-08-29 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N203985-001 | AFINITOR DISPERZ | 2MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203985-002 | AFINITOR DISPERZ | 3MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203985-003 | AFINITOR DISPERZ | 5MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD, RS | 2012-08-29 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203985-001 | AFINITOR DISPERZ | 2MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203985-002 | AFINITOR DISPERZ | 3MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203985-003 | AFINITOR DISPERZ | 5MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD, RS | 2012-08-29 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203985-001 | AFINITOR DISPERZ | 2MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203985-002 | AFINITOR DISPERZ | 3MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203985-003 | AFINITOR DISPERZ | 5MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD, RS | 2012-08-29 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203985-001 | AFINITOR DISPERZ | 2MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203985-002 | AFINITOR DISPERZ | 3MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203985-003 | AFINITOR DISPERZ | 5MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD, RS | 2012-08-29 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203985-001 | AFINITOR DISPERZ | 2MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203985-002 | AFINITOR DISPERZ | 3MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203985-003 | AFINITOR DISPERZ | 5MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD, RS | 2012-08-29 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203985-001 | AFINITOR DISPERZ | 2MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203985-002 | AFINITOR DISPERZ | 3MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203985-003 | AFINITOR DISPERZ | 5MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD, RS | 2012-08-29 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203985-001 | AFINITOR DISPERZ | 2MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203985-002 | AFINITOR DISPERZ | 3MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203985-003 | AFINITOR DISPERZ | 5MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD, RS | 2012-08-29 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N203985-001 | AFINITOR DISPERZ | 2MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N203985-002 | AFINITOR DISPERZ | 3MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N203985-003 | AFINITOR DISPERZ | 5MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD, RS | 2012-08-29 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203985-001 | AFINITOR DISPERZ | 2MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203985-002 | AFINITOR DISPERZ | 3MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203985-003 | AFINITOR DISPERZ | 5MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD, RS | 2012-08-29 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N203985-001 | AFINITOR DISPERZ | 2MG | TABLET, FOR SUSPENSION / ORAL | AB | RLD | 2012-08-29 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N203985-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N203985-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N203985-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N203985-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203985-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203985-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N203985-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N203985-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N203985-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203985-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203985-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203985-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N203985-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203985-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203985-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203985-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203985-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203985-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203985-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203985-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203985-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203985-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203985-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203985-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203985-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203985-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203985-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203985-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203985-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203985-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203985-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203985-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203985-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N203985-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N203985-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N203985-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203985-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203985-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203985-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N203985-001 | AB | 1 | 301d65b070ca… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-001 | 8778962 | 2022-02-18 | U-1541 | 2014-07-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-001 | 8778962 | 2022-02-18 | U-2280 | 2014-07-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-001 | 8778962*PED | 2022-08-18 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-001 | 8617598 | 2022-09-27 | Drug product | 2014-03-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-001 | 8617598*PED | 2023-03-27 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-002 | 8778962 | 2022-02-18 | U-1541 | 2014-07-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-002 | 8778962 | 2022-02-18 | U-2280 | 2014-07-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-002 | 8778962*PED | 2022-08-18 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-002 | 8617598 | 2022-09-27 | Drug product | 2014-03-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-002 | 8617598*PED | 2023-03-27 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-003 | 8778962 | 2022-02-18 | U-1541 | 2014-07-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-003 | 8778962 | 2022-02-18 | U-2280 | 2014-07-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-003 | 8778962*PED | 2022-08-18 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-003 | 8617598 | 2022-09-27 | Drug product | 2014-03-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-003 | 8617598*PED | 2023-03-27 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N203985-001 | 8778962 | 2022-02-18 | U-1541 | 2014-07-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N203985-001 | 8778962 | 2022-02-18 | U-2280 | 2014-07-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N203985-001 | 8778962*PED | 2022-08-18 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N203985-001 | 8617598 | 2022-09-27 | Drug product | 2014-03-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N203985-001 | 8617598*PED | 2023-03-27 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N203985-002 | 8778962 | 2022-02-18 | U-1541 | 2014-07-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N203985-002 | 8778962 | 2022-02-18 | U-2280 | 2014-07-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N203985-002 | 8778962*PED | 2022-08-18 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N203985-002 | 8617598 | 2022-09-27 | Drug product | 2014-03-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N203985-002 | 8617598*PED | 2023-03-27 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N203985-003 | 8778962 | 2022-02-18 | U-1541 | 2014-07-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N203985-003 | 8778962 | 2022-02-18 | U-2280 | 2014-07-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N203985-003 | 8778962*PED | 2022-08-18 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N203985-003 | 8617598 | 2022-09-27 | Drug product | 2014-03-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N203985-003 | 8617598*PED | 2023-03-27 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N203985-001 | 8778962 | 2022-02-18 | U-1541 | 2014-07-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N203985-001 | 8778962 | 2022-02-18 | U-2280 | 2014-07-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N203985-001 | 8778962*PED | 2022-08-18 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N203985-001 | 8617598 | 2022-09-27 | Drug product | 2014-03-27 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N203985-001 | 8617598*PED | 2023-03-27 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N203985-002 | 8778962 | 2022-02-18 | U-1541 | 2014-07-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N203985-002 | 8778962 | 2022-02-18 | U-2280 | 2014-07-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N203985-002 | 8778962*PED | 2022-08-18 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N203985-002 | 8617598 | 2022-09-27 | Drug product | 2014-03-27 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N203985-002 | 8617598*PED | 2023-03-27 | Pediatric extension | 4b0b4de00fa7… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203985-001 | ODE-169 | 2025-04-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203985-002 | ODE-169 | 2025-04-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203985-003 | ODE-169 | 2025-04-10 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N203985-001 | ODE-169 | 2025-04-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203985-002 | ODE-169 | 2025-04-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203985-003 | ODE-169 | 2025-04-10 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203985-001 | ODE-169 | 2025-04-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203985-002 | ODE-169 | 2025-04-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203985-003 | ODE-169 | 2025-04-10 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203985-001 | ODE-169 | 2025-04-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203985-002 | ODE-169 | 2025-04-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203985-003 | ODE-169 | 2025-04-10 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203985-001 | ODE-169 | 2025-04-10 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203985-002 | ODE-169 | 2025-04-10 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203985-003 | ODE-169 | 2025-04-10 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203985-001 | ODE-169 | 2025-04-10 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203985-002 | ODE-169 | 2025-04-10 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203985-003 | ODE-169 | 2025-04-10 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203985-001 | ODE-169 | 2025-04-10 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203985-002 | ODE-169 | 2025-04-10 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203985-003 | ODE-169 | 2025-04-10 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203985-001 | ODE-169 | 2025-04-10 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203985-002 | ODE-169 | 2025-04-10 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203985-003 | ODE-169 | 2025-04-10 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N203985-001 | ODE-169 | 2025-04-10 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N203985-002 | ODE-169 | 2025-04-10 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N203985-003 | ODE-169 | 2025-04-10 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203985-001 | ODE-169 | 2025-04-10 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203985-002 | ODE-169 | 2025-04-10 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203985-003 | ODE-169 | 2025-04-10 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N203985-001 | ODE-169 | 2025-04-10 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N203985-002 | ODE-169 | 2025-04-10 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N203985-003 | ODE-169 | 2025-04-10 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N203985-001 | ODE-169 | 2025-04-10 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N203985-002 | ODE-169 | 2025-04-10 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N203985-003 | ODE-169 | 2025-04-10 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N203985-001 | ODE-169 | 2025-04-10 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N203985-002 | ODE-169 | 2025-04-10 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N203985-003 | ODE-169 | 2025-04-10 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203985-001 | ODE-169 | 2025-04-10 | 5c6f7cd8ea54… |
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 |
|---|---|---|---|---|---|---|
| Afinitor | EVEROLIMUS | Novartis Pharmaceuticals Corporation | 2150f73a-179b-4afc-b8ce-67c85cc72f04 | 2026-06-01 | Warnings, Adverse reactions | 0078-0626-51 00078062651 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.