AUVELITY
- Product NDC
- 81968-453
- 11-digit product format
- 819680453
- Labeler code
- 81968
- Product ID
- 81968-453_948d108e-f3a6-4e83-a4f2-ff8edf184e1b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dextromethorphan hydrobromide, bupropion hydrochloride
- Dosage form
- KIT
- Labeler
- Axsome Therapeutics, Inc.
- Application
- NDA215430
- Marketing category
- NDA
- Marketing start
- 2026-07-30
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N215430-001 | AUVELITY | BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | |
| N215430-002 | AUVELITY | BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 105MG;30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2026-04-30 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N215430-001 | 8569328 | 2032-07-18 | U-3419 | Drug product | 2022-09-16 |
| N215430-001 | 8569328 | 2032-07-18 | U-4516 | Drug product | 2022-09-16 |
| N215430-001 | 10058518 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10058518 | 2034-11-05 | U-4522 | 2022-09-16 | |
| N215430-001 | 10064857 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10064857 | 2034-11-05 | U-4517 | 2022-09-16 | |
| N215430-001 | 10080727 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10080727 | 2034-11-05 | U-4520 | 2022-09-16 | |
| N215430-001 | 10092560 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10092560 | 2034-11-05 | U-4517 | 2022-09-16 | |
| N215430-001 | 10092561 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10092561 | 2034-11-05 | U-4517 | 2022-09-16 | |
| N215430-001 | 10105327 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10105361 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10105361 | 2034-11-05 | U-4522 | 2022-09-16 | |
| N215430-001 | 10251879 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10251879 | 2034-11-05 | U-4517 | 2022-09-16 | |
| N215430-001 | 10463634 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10463634 | 2034-11-05 | U-4517 | 2022-09-16 | |
| N215430-001 | 10512643 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10512643 | 2034-11-05 | U-4517 | 2022-09-16 | |
| N215430-001 | 10548857 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10596167 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10596167 | 2034-11-05 | U-4517 | 2022-09-16 | |
| N215430-001 | 10772850 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10780066 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10780066 | 2034-11-05 | U-4517 | 2022-09-16 | |
| N215430-001 | 10786469 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10786496 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10786496 | 2034-11-05 | U-4517 | 2022-09-16 | |
| N215430-001 | 10799497 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10806710 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10806710 | 2034-11-05 | U-4517 | 2022-09-16 | |
| N215430-001 | 10864209 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10874663 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10874664 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10874665 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10881624 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10881624 | 2034-11-05 | U-4517 | 2022-09-16 | |
| N215430-001 | 10881657 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10894046 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10894047 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10898453 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10933034 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10945973 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10966941 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 10966941 | 2034-11-05 | U-4517 | 2022-09-16 | |
| N215430-001 | 10966974 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11007189 | 2034-11-05 | U-4516 | 2026-05-29 | |
| N215430-001 | 11020389 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11058648 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11065248 | 2034-11-05 | U-3419 | 2025-11-20 | |
| N215430-001 | 11065248 | 2034-11-05 | U-4517 | 2025-11-20 | |
| N215430-001 | 11090300 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11096937 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11123343 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11123344 | 2034-11-05 | U-3419 | 2025-11-20 | |
| N215430-001 | 11123344 | 2034-11-05 | U-4517 | 2025-11-20 | |
| N215430-001 | 11129826 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11141388 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11141416 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11147808 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11185515 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11191739 | 2034-11-05 | U-3419 | Drug product | 2022-09-16 |
| N215430-001 | 11191739 | 2034-11-05 | U-4516 | Drug product | 2022-09-16 |
| N215430-001 | 11197839 | 2034-11-05 | U-3419 | Drug product | 2022-09-16 |
| N215430-001 | 11197839 | 2034-11-05 | U-4516 | Drug product | 2022-09-16 |
| N215430-001 | 11207281 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11207281 | 2034-11-05 | U-4537 | 2022-09-16 | |
| N215430-001 | 11213521 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11229640 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11234946 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11234946 | 2034-11-05 | U-4526 | 2022-09-16 | |
| N215430-001 | 11253491 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11253492 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11253492 | 2034-11-05 | U-4526 | 2022-09-16 | |
| N215430-001 | 11273133 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11273133 | 2034-11-05 | U-4526 | 2022-09-16 | |
| N215430-001 | 11273134 | 2034-11-05 | U-3419 | 2022-09-16 | |
| N215430-001 | 11273134 | 2034-11-05 | U-4517 | 2022-09-16 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N215430-001 | I-913 | 2029-04-30 |
| N215430-002 | I-913 | 2029-04-30 |
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 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-002 | AUVELITY | 105MG;30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2026-04-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215430-002 | AUVELITY | 105MG;30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2026-04-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | e64feba35796… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N215430-001 | AUVELITY | 105MG;45MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2022-08-18 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N215430-002 | AUVELITY | 105MG;30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2026-04-30 | a50c72e98297… |
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 | N215430-001 | 8569328 | 2032-07-18 | U-3419 | Drug product | 2022-09-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 8569328 | 2032-07-18 | U-4516 | Drug product | 2022-09-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10058518 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10058518 | 2034-11-05 | U-4522 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10064857 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10064857 | 2034-11-05 | U-4517 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10080727 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10080727 | 2034-11-05 | U-4520 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10092560 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10092560 | 2034-11-05 | U-4517 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10092561 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10092561 | 2034-11-05 | U-4517 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10105327 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10105361 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10105361 | 2034-11-05 | U-4522 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10251879 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10251879 | 2034-11-05 | U-4517 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10463634 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10463634 | 2034-11-05 | U-4517 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10512643 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10512643 | 2034-11-05 | U-4517 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10548857 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10596167 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10596167 | 2034-11-05 | U-4517 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10772850 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10780066 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10780066 | 2034-11-05 | U-4517 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10786469 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10786496 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10786496 | 2034-11-05 | U-4517 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10799497 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10806710 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10806710 | 2034-11-05 | U-4517 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10864209 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10874663 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10874664 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10874665 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10881624 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10881624 | 2034-11-05 | U-4517 | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | 10881657 | 2034-11-05 | U-3419 | 2022-09-16 | 84e616aacf4f… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N215430-001 | I-913 | 2029-04-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N215430-002 | I-913 | 2029-04-30 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N215430-001 | I-913 | 2029-04-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N215430-002 | I-913 | 2029-04-30 | caaa826d4ba7… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215430-001 | NP | 2025-08-18 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N215430-001 | NP | 2025-08-18 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215430-001 | NP | 2025-08-18 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215430-001 | NP | 2025-08-18 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215430-001 | NP | 2025-08-18 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215430-001 | NP | 2025-08-18 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215430-001 | NP | 2025-08-18 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215430-001 | NP | 2025-08-18 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N215430-001 | NP | 2025-08-18 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215430-001 | NP | 2025-08-18 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215430-001 | NP | 2025-08-18 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215430-001 | NP | 2025-08-18 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N215430-001 | NP | 2025-08-18 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215430-001 | NP | 2025-08-18 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N215430-001 | NP | 2025-08-18 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N215430-001 | NP | 2025-08-18 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215430-001 | NP | 2025-08-18 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215430-001 | NP | 2025-08-18 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215430-001 | NP | 2025-08-18 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N215430-001 | NP | 2025-08-18 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N215430-001 | NP | 2025-08-18 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N215430-001 | NP | 2025-08-18 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N215430-001 | NP | 2025-08-18 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N215430-001 | NP | 2025-08-18 | f41ea6bd6efb… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N215430-001 | I-913 | 2029-04-30 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N215430-002 | I-913 | 2029-04-30 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AUVELITY
- Listing expiration
- 2027-12-31
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| ZG7E5POY8O | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2611260 | Internal RxNorm lookup |
| 2611266 | Internal RxNorm lookup |
| 2741701 | Internal RxNorm lookup |
| 2741703 | Internal RxNorm lookup |
| 2744512 | Internal RxNorm lookup |
| 2744513 | Internal RxNorm lookup |
| 2744514 | Internal RxNorm lookup |
| 2744515 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| dcefda7c-9a68-278e-e053-2995a90aec79 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4eceb285-f3c7-4092-a21a-4c9f3169f20c | Product name | 5 | 20260220 |
| 548ba7fd-fd0c-4a21-b2b0-d01bf93143b8 | Product name | 3 | 20240209 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| b8ee525f-67fb-39fb-91da-7e47ac54581d | Product name | 5 | 20200611 |
| 2e254488-9fcb-41b3-a7c3-e2c9a3941b29 | Product name | 1 | 20200603 |
| b4ff0805-126a-406d-9cae-fc34fd8e8889 | Product name | 1 | 20190711 |
| 98e65af1-f5d0-75d5-c930-f8a4ce4c3284 | Product name | 9 | 20190211 |
| e4d463bc-c674-43cb-be06-82786f310d01 | Product name | 1 | 20150326 |
| 0916dcfb-331f-89b1-8eac-6f7dc76d82da | Product name | 1 | 20140508 |
| d7fc3d53-5a6c-de82-2808-1780f175f17e | Product name | 1 | 20140508 |
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 |
|---|---|---|---|---|---|---|
| AUVELITY | DEXTROMETHORPHAN HYDROBROMIDE, BUPROPION HYDROCHLORIDE | Axsome Therapeutics, Inc. | dcefda7c-9a68-278e-e053-2995a90aec79 | 2026-08-17 | Boxed warning, Warnings, Adverse reactions | 215430 NDA215430 81968-453 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 81968-453-01 | 81968045301 | 1 KIT in 1 KIT (81968-453-01) * 1 BOTTLE in 1 CARTON / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE | 1 kit | 2026-07-30 | Yes | No | Current |