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 01:56:54
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0078-0620-51 | EA - Each | 0078-0620 | 66e523f0-c42f-4367-839b-6f57d2d379cd | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0078-0620 | 0078-0620-51 |
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 |
|---|---|---|---|---|---|---|---|
| N022334-001 | AFINITOR | EVEROLIMUS | 5MG | TABLET / ORAL | AB | RLD, RS | 2009-03-30 |
| N022334-002 | AFINITOR | EVEROLIMUS | 10MG | TABLET / ORAL | AB | RLD | 2009-03-30 |
| N022334-003 | AFINITOR | EVEROLIMUS | 2.5MG | TABLET / ORAL | AB | RLD | 2010-07-09 |
| N022334-004 | AFINITOR | EVEROLIMUS | 7.5MG | TABLET / ORAL | AB | RLD | 2012-03-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022334-001 | AB |
| N022334-002 | AB |
| N022334-003 | AB |
| N022334-004 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022334-001 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | |
| N022334-001 | 8410131*PED | 2026-05-01 | Pediatric extension | ||
| N022334-001 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | |
| N022334-002 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | |
| N022334-002 | 8410131*PED | 2026-05-01 | Pediatric extension | ||
| N022334-002 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | |
| N022334-003 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | |
| N022334-003 | 8410131*PED | 2026-05-01 | Pediatric extension | ||
| N022334-003 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | |
| N022334-004 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | |
| N022334-004 | 8410131*PED | 2026-05-01 | Pediatric extension | ||
| N022334-004 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 |
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 | N022334-001 | AFINITOR | 5MG | TABLET / ORAL | AB | RLD, RS | 2009-03-30 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022334-002 | AFINITOR | 10MG | TABLET / ORAL | AB | RLD | 2009-03-30 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022334-003 | AFINITOR | 2.5MG | TABLET / ORAL | AB | RLD | 2010-07-09 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022334-004 | AFINITOR | 7.5MG | TABLET / ORAL | AB | RLD | 2012-03-30 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N022334-001 | AFINITOR | 5MG | TABLET / ORAL | AB | RLD, RS | 2009-03-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022334-002 | AFINITOR | 10MG | TABLET / ORAL | AB | RLD | 2009-03-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022334-003 | AFINITOR | 2.5MG | TABLET / ORAL | AB | RLD | 2010-07-09 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022334-004 | AFINITOR | 7.5MG | TABLET / ORAL | AB | RLD | 2012-03-30 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022334-001 | AFINITOR | 5MG | TABLET / ORAL | AB | RLD, RS | 2009-03-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022334-002 | AFINITOR | 10MG | TABLET / ORAL | AB | RLD | 2009-03-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022334-003 | AFINITOR | 2.5MG | TABLET / ORAL | AB | RLD | 2010-07-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022334-004 | AFINITOR | 7.5MG | TABLET / ORAL | AB | RLD | 2012-03-30 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022334-001 | AFINITOR | 5MG | TABLET / ORAL | AB | RLD, RS | 2009-03-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022334-002 | AFINITOR | 10MG | TABLET / ORAL | AB | RLD | 2009-03-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022334-003 | AFINITOR | 2.5MG | TABLET / ORAL | AB | RLD | 2010-07-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022334-004 | AFINITOR | 7.5MG | TABLET / ORAL | AB | RLD | 2012-03-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022334-001 | AFINITOR | 5MG | TABLET / ORAL | AB | RLD, RS | 2009-03-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022334-002 | AFINITOR | 10MG | TABLET / ORAL | AB | RLD | 2009-03-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022334-003 | AFINITOR | 2.5MG | TABLET / ORAL | AB | RLD | 2010-07-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022334-004 | AFINITOR | 7.5MG | TABLET / ORAL | AB | RLD | 2012-03-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022334-001 | AFINITOR | 5MG | TABLET / ORAL | AB | RLD, RS | 2009-03-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022334-002 | AFINITOR | 10MG | TABLET / ORAL | AB | RLD | 2009-03-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022334-003 | AFINITOR | 2.5MG | TABLET / ORAL | AB | RLD | 2010-07-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022334-004 | AFINITOR | 7.5MG | TABLET / ORAL | AB | RLD | 2012-03-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022334-001 | AFINITOR | 5MG | TABLET / ORAL | AB | RLD, RS | 2009-03-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022334-002 | AFINITOR | 10MG | TABLET / ORAL | AB | RLD | 2009-03-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022334-003 | AFINITOR | 2.5MG | TABLET / ORAL | AB | RLD | 2010-07-09 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022334-004 | AFINITOR | 7.5MG | TABLET / ORAL | AB | RLD | 2012-03-30 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022334-001 | AFINITOR | 5MG | TABLET / ORAL | AB | RLD, RS | 2009-03-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022334-002 | AFINITOR | 10MG | TABLET / ORAL | AB | RLD | 2009-03-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022334-003 | AFINITOR | 2.5MG | TABLET / ORAL | AB | RLD | 2010-07-09 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022334-004 | AFINITOR | 7.5MG | TABLET / ORAL | AB | RLD | 2012-03-30 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022334-001 | AFINITOR | 5MG | TABLET / ORAL | AB | RLD, RS | 2009-03-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022334-002 | AFINITOR | 10MG | TABLET / ORAL | AB | RLD | 2009-03-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022334-003 | AFINITOR | 2.5MG | TABLET / ORAL | AB | RLD | 2010-07-09 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022334-004 | AFINITOR | 7.5MG | TABLET / ORAL | AB | RLD | 2012-03-30 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022334-001 | AFINITOR | 5MG | TABLET / ORAL | AB | RLD, RS | 2009-03-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022334-002 | AFINITOR | 10MG | TABLET / ORAL | AB | RLD | 2009-03-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022334-003 | AFINITOR | 2.5MG | TABLET / ORAL | AB | RLD | 2010-07-09 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022334-004 | AFINITOR | 7.5MG | TABLET / ORAL | AB | RLD | 2012-03-30 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N022334-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022334-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022334-003 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022334-004 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N022334-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022334-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022334-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022334-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022334-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022334-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022334-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022334-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022334-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022334-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022334-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022334-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022334-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022334-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022334-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022334-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022334-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022334-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022334-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022334-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022334-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022334-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022334-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022334-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022334-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022334-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022334-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022334-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022334-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022334-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022334-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022334-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022334-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022334-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022334-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022334-004 | AB | 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 | N022334-001 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N022334-001 | 8410131*PED | 2026-05-01 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N022334-001 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N022334-002 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N022334-002 | 8410131*PED | 2026-05-01 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N022334-002 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N022334-003 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N022334-003 | 8410131*PED | 2026-05-01 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N022334-003 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N022334-004 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N022334-004 | 8410131*PED | 2026-05-01 | Pediatric extension | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N022334-004 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N022334-001 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022334-001 | 8410131*PED | 2026-05-01 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022334-001 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022334-002 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022334-002 | 8410131*PED | 2026-05-01 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022334-002 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022334-003 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022334-003 | 8410131*PED | 2026-05-01 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022334-003 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022334-004 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022334-004 | 8410131*PED | 2026-05-01 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022334-004 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022334-001 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022334-001 | 8410131*PED | 2026-05-01 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022334-001 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022334-002 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022334-002 | 8410131*PED | 2026-05-01 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022334-002 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022334-003 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022334-003 | 8410131*PED | 2026-05-01 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022334-003 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022334-004 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022334-004 | 8410131*PED | 2026-05-01 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022334-004 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022334-001 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022334-001 | 8410131*PED | 2026-05-01 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022334-001 | 9006224 | 2028-07-01 | U-1681 | 2015-04-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022334-002 | 8410131 | 2025-11-01 | U-1368 | 2013-04-02 | 011fe1cb6892… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022334-001 | ODE-108 | 2023-02-26 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022334-002 | ODE-108 | 2023-02-26 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022334-003 | ODE-108 | 2023-02-26 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022334-004 | ODE-108 | 2023-02-26 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022334-001 | ODE-108 | 2023-02-26 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022334-002 | ODE-108 | 2023-02-26 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022334-003 | ODE-108 | 2023-02-26 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022334-004 | ODE-108 | 2023-02-26 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022334-001 | ODE-108 | 2023-02-26 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022334-002 | ODE-108 | 2023-02-26 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022334-003 | ODE-108 | 2023-02-26 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022334-004 | ODE-108 | 2023-02-26 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-001 | I-724 | 2019-02-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-001 | ODE-24 | 2019-04-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-001 | PED | 2019-10-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-001 | ODE-108 | 2023-02-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-002 | I-724 | 2019-02-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-002 | ODE-24 | 2019-04-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-002 | PED | 2019-10-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-002 | ODE-108 | 2023-02-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-003 | I-724 | 2019-02-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-003 | ODE-24 | 2019-04-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-003 | PED | 2019-10-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-003 | ODE-108 | 2023-02-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-004 | I-724 | 2019-02-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-004 | ODE-24 | 2019-04-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-004 | PED | 2019-10-26 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022334-004 | ODE-108 | 2023-02-26 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022334-001 | ODE-108 | 2023-02-26 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022334-002 | ODE-108 | 2023-02-26 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022334-003 | ODE-108 | 2023-02-26 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022334-004 | ODE-108 | 2023-02-26 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022334-001 | ODE-108 | 2023-02-26 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022334-002 | ODE-108 | 2023-02-26 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022334-003 | ODE-108 | 2023-02-26 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022334-004 | ODE-108 | 2023-02-26 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022334-001 | ODE-108 | 2023-02-26 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022334-002 | ODE-108 | 2023-02-26 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022334-003 | ODE-108 | 2023-02-26 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022334-004 | ODE-108 | 2023-02-26 | 87673890dc5c… |
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 | 0078-0620-51 00078062051 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.