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 03:21:11
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62541-202-30 | EA - Each | 62541-202 | b72f0086-6c68-4e2a-8e4f-6669412f86cf | 1 | 2013-02-13 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62541-202 | 62541-202-30 |
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 |
|---|---|---|---|---|---|---|---|
| N022580-001 | QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 |
| N022580-002 | QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 |
| N022580-003 | QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 |
| N022580-004 | QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022580-001 | AB |
| N022580-002 | AB |
| N022580-003 | AB |
| N022580-004 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022580-001 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | |
| N022580-001 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | |
| N022580-001 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | |
| N022580-001 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | |
| N022580-001 | 8580298 | 2029-05-15 | Drug product | 2013-11-14 | |
| N022580-001 | 8580299 | 2029-06-14 | U-3399 | 2013-11-14 | |
| N022580-002 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | |
| N022580-002 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | |
| N022580-002 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | |
| N022580-002 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | |
| N022580-002 | 8580298 | 2029-05-15 | Drug product | ||
| N022580-002 | 8580299 | 2029-06-14 | U-3399 | ||
| N022580-003 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | |
| N022580-003 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | |
| N022580-003 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | |
| N022580-003 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | |
| N022580-003 | 8580298 | 2029-05-15 | Drug product | ||
| N022580-003 | 8580299 | 2029-06-14 | U-3399 | ||
| N022580-004 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | |
| N022580-004 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | |
| N022580-004 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | |
| N022580-004 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | |
| N022580-004 | 8580298 | 2029-05-15 | Drug product | ||
| N022580-004 | 8580299 | 2029-06-14 | U-3399 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N022580-001 | M-308 | 2027-09-13 |
| N022580-002 | M-308 | 2027-09-13 |
| N022580-003 | M-308 | 2027-09-13 |
| N022580-004 | M-308 | 2027-09-13 |
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 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022580-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022580-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022580-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022580-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022580-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022580-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022580-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022580-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-004 | AB | 1 | 5bbf6a4d5a75… |
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 | N022580-001 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-001 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-001 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-001 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-001 | 8580298 | 2029-05-15 | Drug product | 2013-11-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-001 | 8580299 | 2029-06-14 | U-3399 | 2013-11-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-002 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-002 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-002 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-002 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-002 | 8580298 | 2029-05-15 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022580-002 | 8580299 | 2029-06-14 | U-3399 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022580-003 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-003 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-003 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-003 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-003 | 8580298 | 2029-05-15 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022580-003 | 8580299 | 2029-06-14 | U-3399 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022580-004 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-004 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-004 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-004 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022580-004 | 8580298 | 2029-05-15 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022580-004 | 8580299 | 2029-06-14 | U-3399 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022580-001 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022580-001 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022580-001 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022580-001 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022580-001 | 8580298 | 2029-05-15 | Drug product | 2013-11-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022580-001 | 8580299 | 2029-06-14 | U-3399 | 2013-11-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022580-002 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022580-002 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022580-002 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022580-002 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022580-002 | 8580298 | 2029-05-15 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022580-002 | 8580299 | 2029-06-14 | U-3399 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022580-003 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022580-003 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022580-003 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022580-003 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | caaa826d4ba7… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022580-001 | M-308 | 2027-09-13 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022580-002 | M-308 | 2027-09-13 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022580-003 | M-308 | 2027-09-13 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022580-004 | M-308 | 2027-09-13 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022580-001 | M-308 | 2027-09-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022580-002 | M-308 | 2027-09-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022580-003 | M-308 | 2027-09-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022580-004 | M-308 | 2027-09-13 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-001 | M-308 | 2027-09-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-002 | M-308 | 2027-09-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-003 | M-308 | 2027-09-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-004 | M-308 | 2027-09-13 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-001 | NPP | 2025-06-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-001 | M-308 | 2027-09-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-002 | NPP | 2025-06-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-002 | M-308 | 2027-09-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-003 | NPP | 2025-06-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-003 | M-308 | 2027-09-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-004 | NPP | 2025-06-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-004 | M-308 | 2027-09-13 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-001 | NPP | 2025-06-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-001 | M-308 | 2027-09-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-002 | NPP | 2025-06-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-002 | M-308 | 2027-09-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-003 | NPP | 2025-06-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-003 | M-308 | 2027-09-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-004 | NPP | 2025-06-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-004 | M-308 | 2027-09-13 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-001 | NPP | 2025-06-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-001 | M-308 | 2027-09-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-002 | NPP | 2025-06-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-002 | M-308 | 2027-09-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-003 | NPP | 2025-06-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-003 | M-308 | 2027-09-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-004 | NPP | 2025-06-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-004 | M-308 | 2027-09-13 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-001 | NPP | 2025-06-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-001 | M-308 | 2027-09-13 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-002 | NPP | 2025-06-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-002 | M-308 | 2027-09-13 | b8a1b40f171c… |
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 |
|---|---|---|---|---|---|---|
| Qsymia | PHENTERMINE AND TOPIRAMATE | Vivus LLC | 40dd5602-53da-45ac-bb4b-15789aba40f9 | 2026-04-22 | Warnings, Adverse reactions | 62541-202-30 62541020230 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.