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AUVELITY
dextromethorphan hydrobromide, bupropion hydrochloride · Tablet, Multilayer, Extended Release
Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from
public FDA and NLM data. Always confirm against the manufacturer's current
prescribing information. Report adverse events to FDA MedWatch.
Overview
Brand name
AUVELITY
Generic name
dextromethorphan hydrobromide, bupropion hydrochloride
Dosage form
Tablet, Multilayer, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Axsome Therapeutics, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
2
Packages
5
Data completeness
54%
of corroborating sources present
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryDosage form
Tablet, Multilayer, Extended Release
Route of administration
Oral
Presentations
7
Pharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Aminoketone [EPC] | EPC | All 13 members |
| Dopamine Uptake Inhibitors [MoA] | MoA | All 14 members |
| Increased Dopamine Activity [PE] | PE | All 13 members |
| Increased Norepinephrine Activity [PE] | PE | All 17 members |
| Norepinephrine Uptake Inhibitors [MoA] | MoA | All 44 members |
| Sigma-1 Agonist [EPC] | EPC | All 44 members |
| Sigma-1 Receptor Agonists [MoA] | MoA | All 44 members |
| Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] | EPC | All 44 members |
| Uncompetitive NMDA Receptor Antagonists [MoA] | MoA | All 44 members |
Regulatory status
Source: Drugs@FDANDC DirectoryApplication number
215430
Application type
NDA · New Drug Application
Approval date
August 18, 2022
Sponsor
AXSOME
Products on application
2
Submissions recorded
5
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 215430-001 | AUVELITY | TABLET, EXTENDED RELEASE | BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | Prescription | — | RLD RS | |
| 215430-002 | AUVELITY | TABLET, EXTENDED RELEASE | BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | Prescription | — | RLD |
Therapeutic equivalence
Source: Orange BookTE code
—
Reference Listed Drug
Yes
Reference Standard
Yes
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Patents and exclusivity
Source: Orange Book| Patent | Expires | Product | Substance | Use code | Submitted |
|---|---|---|---|---|---|
| 8569328 | July 18, 2032 | 001 | No | U-3419 | September 16, 2022 |
| 8569328 | July 18, 2032 | 001 | No | U-4516 | September 16, 2022 |
| 8569328 | July 18, 2032 | 002 | No | U-4516 | May 29, 2026 |
| 11524008 | November 5, 2034 | 001 | No | U-3419 | December 21, 2022 |
| 11524007 | November 5, 2034 | 001 | No | U-3419 | December 21, 2022 |
| 11517542 | November 5, 2034 | 001 | No | U-3419 | December 21, 2022 |
| 11517543 | November 5, 2034 | 001 | No | U-3419 | December 21, 2022 |
| 11510918 | November 5, 2034 | 001 | No | U-3419 | December 7, 2022 |
| 11382874 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11364233 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9457025 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10058518 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9278095 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9867819 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9168234 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9861595 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9700553 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11357744 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11344544 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9486450 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9474731 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9375429 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9421176 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9408815 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9763932 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11311534 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9205083 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9707191 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10898453 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11433067 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9700528 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9370513 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9457023 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9238032 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11096937 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11298352 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10966941 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11298351 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11090300 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10894047 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10064857 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11291665 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10780066 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11291638 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10786469 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11253492 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10881657 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10874663 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10799497 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11058648 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11273133 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10864209 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10806710 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10881624 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10786496 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11020389 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11185515 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10945973 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11285146 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11285118 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10596167 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11439636 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9314462 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9198905 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11426401 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11426370 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11419867 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10772850 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11273134 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11253491 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11234946 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10548857 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11229640 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10874665 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10933034 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10251879 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10092561 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10894046 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11191739 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10874664 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10080727 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11197839 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11147808 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11207281 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11141416 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11141388 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11213521 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11129826 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11123343 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10966974 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10512643 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10463634 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10105361 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10105327 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 10092560 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 9968568 | November 5, 2034 | 001 | No | U-3419 | September 16, 2022 |
| 11969421 | November 5, 2034 | 001 | No | U-3419 | May 7, 2024 |
| 11590124 | November 5, 2034 | 001 | No | U-3419 | November 20, 2025 |
| 11576909 | November 5, 2034 | 001 | No | U-3419 | November 20, 2025 |
| 11571417 | November 5, 2034 | 001 | No | U-3419 | November 20, 2025 |
| 11123344 | November 5, 2034 | 001 | No | U-3419 | November 20, 2025 |
| 11065248 | November 5, 2034 | 001 | No | U-3419 | November 20, 2025 |
| 11478468 | November 5, 2034 | 001 | No | U-3419 | November 10, 2022 |
| 11541048 | November 5, 2034 | 001 | No | U-3419 | January 23, 2023 |
| 11541021 | November 5, 2034 | 001 | No | U-3419 | January 23, 2023 |
| 11534414 | November 5, 2034 | 001 | No | U-3419 | January 23, 2023 |
| 11779579 | November 5, 2034 | 001 | No | U-3419 | October 12, 2023 |
| 11617728 | November 5, 2034 | 001 | No | U-3419 | May 3, 2023 |
| 11617747 | November 5, 2034 | 001 | No | U-3563 | May 3, 2023 |
| 11596627 | November 5, 2034 | 001 | No | U-3419 | April 4, 2023 |
| 11497721 | November 5, 2034 | 001 | No | U-3419 | December 2, 2022 |
| 12109178 | November 5, 2034 | 001 | No | U-3419 | October 15, 2024 |
| 9968568 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 11285146 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 9168234 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 11382874 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 11344544 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 11571417 | November 5, 2034 | 001 | No | U-4526 | November 20, 2025 |
| 11298352 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 11007189 | November 5, 2034 | 001 | No | U-4516 | May 29, 2026 |
| 11534414 | November 5, 2034 | 001 | No | U-4516 | January 23, 2023 |
| 11191739 | November 5, 2034 | 001 | No | U-4516 | September 16, 2022 |
| 11197839 | November 5, 2034 | 001 | No | U-4516 | September 16, 2022 |
| 11234946 | November 5, 2034 | 001 | No | U-4526 | September 16, 2022 |
| 10881624 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 9861595 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 9486450 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 9314462 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 9205083 | November 5, 2034 | 001 | No | U-4520 | September 16, 2022 |
| 10092560 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 11207281 | November 5, 2034 | 001 | No | U-4537 | September 16, 2022 |
| 9457025 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 9421176 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 9370513 | November 5, 2034 | 001 | No | U-4520 | September 16, 2022 |
| 9707191 | November 5, 2034 | 001 | No | U-4522 | September 16, 2022 |
| 9474731 | November 5, 2034 | 001 | No | U-4520 | September 16, 2022 |
| 11590124 | November 5, 2034 | 001 | No | U-4526 | November 20, 2025 |
| 11253492 | November 5, 2034 | 001 | No | U-4526 | September 16, 2022 |
| 9198905 | November 5, 2034 | 001 | No | U-4520 | September 16, 2022 |
| 10064857 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 11426370 | November 5, 2034 | 001 | No | U-4526 | September 16, 2022 |
| 10092561 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 10780066 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 10058518 | November 5, 2034 | 001 | No | U-4522 | September 16, 2022 |
| 11273134 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 11273133 | November 5, 2034 | 001 | No | U-4526 | September 16, 2022 |
| 11065248 | November 5, 2034 | 001 | No | U-4517 | November 20, 2025 |
| 11433067 | November 5, 2034 | 001 | No | U-4516 | September 16, 2022 |
| 11357744 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 11576909 | November 5, 2034 | 001 | No | U-4526 | November 20, 2025 |
| 11439636 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 11426401 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 10966941 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 10806710 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 10596167 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 11291638 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 11285118 | November 5, 2034 | 001 | No | U-4526 | September 16, 2022 |
| 11419867 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 11291665 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 9278095 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 9867819 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 9763932 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 9700553 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 9700528 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 9457023 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 11123344 | November 5, 2034 | 001 | No | U-4517 | November 20, 2025 |
| 10786496 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 10105361 | November 5, 2034 | 001 | No | U-4522 | September 16, 2022 |
| 9238032 | November 5, 2034 | 001 | No | U-4520 | September 16, 2022 |
| 9375429 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 10512643 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 10080727 | November 5, 2034 | 001 | No | U-4520 | September 16, 2022 |
| 10251879 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 9408815 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 10463634 | November 5, 2034 | 001 | No | U-4517 | September 16, 2022 |
| 11617747 | November 5, 2034 | 001 | No | U-4526 | May 3, 2023 |
| 9968568 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 9168234 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 10080727 | November 5, 2034 | 002 | No | U-4520 | May 29, 2026 |
| 11590124 | November 5, 2034 | 002 | No | U-4526 | May 29, 2026 |
| 11291638 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 11007189 | November 5, 2034 | 002 | No | U-4516 | May 29, 2026 |
| 9700528 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 11253492 | November 5, 2034 | 002 | No | U-4526 | May 29, 2026 |
| 9861595 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 9700553 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 9486450 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 9370513 | November 5, 2034 | 002 | No | U-4520 | May 29, 2026 |
| 9375429 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 9314462 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 9457023 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 11207281 | November 5, 2034 | 002 | No | U-4537 | May 29, 2026 |
| 10092560 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 10780066 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 9198905 | November 5, 2034 | 002 | No | U-4520 | May 29, 2026 |
| 9205083 | November 5, 2034 | 002 | No | U-4520 | May 29, 2026 |
| 9707191 | November 5, 2034 | 002 | No | U-4522 | May 29, 2026 |
| 10058518 | November 5, 2034 | 002 | No | U-4522 | May 29, 2026 |
| 11571417 | November 5, 2034 | 002 | No | U-4526 | May 29, 2026 |
| 10105361 | November 5, 2034 | 002 | No | U-4522 | May 29, 2026 |
| 10251879 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 11285146 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 11273134 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 11273133 | November 5, 2034 | 002 | No | U-4526 | May 29, 2026 |
| 11298352 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 11344544 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 11426370 | November 5, 2034 | 002 | No | U-4526 | May 29, 2026 |
| 11382874 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 11234946 | November 5, 2034 | 002 | No | U-4526 | May 29, 2026 |
| 9763932 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 11617747 | November 5, 2034 | 002 | No | U-4526 | May 29, 2026 |
| 11285118 | November 5, 2034 | 002 | No | U-4526 | May 29, 2026 |
| 11419867 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 11291665 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 9421176 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 9408815 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 9238032 | November 5, 2034 | 002 | No | U-4520 | May 29, 2026 |
| 9474731 | November 5, 2034 | 002 | No | U-4520 | May 29, 2026 |
| 9457025 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 9867819 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 10092561 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 9278095 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 10512643 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 10463634 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 10881624 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 10064857 | November 5, 2034 | 002 | No | U-4517 | May 29, 2026 |
| 10780064 | January 7, 2040 | 001 | No | U-3419 | September 16, 2022 |
| 10966942 | January 7, 2040 | 001 | No | U-3419 | September 16, 2022 |
| 10940124 | January 7, 2040 | 001 | No | U-3419 | September 16, 2022 |
| 10925842 | January 7, 2040 | 001 | No | U-3419 | September 16, 2022 |
| 12576078 | June 5, 2040 | 001 | No | U-4516 | May 29, 2026 |
| 12433884 | June 5, 2040 | 001 | No | U-4514 | May 29, 2026 |
| 12472156 | June 5, 2040 | 001 | No | U-4516 | May 29, 2026 |
| 12576078 | June 5, 2040 | 002 | No | U-4516 | May 29, 2026 |
| 12433884 | June 5, 2040 | 002 | No | U-4514 | May 29, 2026 |
| 12472156 | June 5, 2040 | 002 | No | U-4516 | May 29, 2026 |
| 12390428 | December 1, 2041 | 001 | No | U-3419 | August 26, 2025 |
| 11896563 | December 1, 2041 | 001 | No | U-3419 | February 16, 2024 |
| 12310961 | January 20, 2043 | 001 | No | U-3419 | June 3, 2025 |
| 11925636 | January 20, 2043 | 001 | No | U-3419 | March 14, 2024 |
| 12357697 | January 20, 2043 | 001 | No | U-3419 | July 29, 2025 |
| 11717518 | January 20, 2043 | 001 | No | U-3419 | August 15, 2023 |
| 12661408 | January 20, 2043 | 001 | No | U-3419 | July 14, 2026 |
| 12239642 | January 20, 2043 | 001 | No | U-4515 | May 29, 2026 |
| 12472174 | January 20, 2043 | 001 | No | U-4515 | May 29, 2026 |
| 12263161 | January 20, 2043 | 001 | No | U-4515 | May 29, 2026 |
| 12564587 | January 20, 2043 | 001 | No | U-4515 | May 29, 2026 |
| 12478622 | January 20, 2043 | 001 | No | U-4515 | May 29, 2026 |
| 12678506 | January 20, 2043 | 001 | No | August 12, 2026 | |
| 12156914 | January 20, 2043 | 001 | No | December 19, 2024 | |
| 12472174 | January 20, 2043 | 002 | No | U-4515 | May 29, 2026 |
| 12678506 | January 20, 2043 | 002 | No | August 12, 2026 | |
| 11730706 | January 23, 2043 | 001 | No | U-3419 | August 28, 2023 |
| 11883373 | January 23, 2043 | 001 | No | U-3419 | February 8, 2024 |
| 12194005 | January 23, 2043 | 001 | No | U-4523 | May 29, 2026 |
| 12364674 | January 23, 2043 | 001 | No | U-4516 | May 29, 2026 |
| 12036191 | February 15, 2043 | 001 | No | U-3419 | August 5, 2024 |
| 11986444 | February 15, 2043 | 001 | No | U-3419 | May 31, 2024 |
| 12370154 | February 15, 2043 | 001 | No | U-4518 | May 29, 2026 |
| 12599576 | February 15, 2043 | 001 | No | U-4518 | May 29, 2026 |
| 12146889 | February 23, 2043 | 001 | No | U-3419 | November 20, 2024 |
| 11752144 | February 23, 2043 | 001 | No | U-3419 | September 14, 2023 |
| 12042473 | February 23, 2043 | 001 | No | U-3419 | August 5, 2024 |
| 12472155 | February 23, 2043 | 001 | No | U-4519 | May 29, 2026 |
| 11839612 | March 2, 2043 | 001 | No | U-3419 | January 5, 2024 |
| 11844797 | April 20, 2043 | 001 | No | U-3778 | January 5, 2024 |
| 12194036 | April 20, 2043 | 001 | No | U-4521 | May 29, 2026 |
| 12653795 | November 28, 2043 | 001 | No | U-4516 | July 14, 2026 |
| Code | Expires | Product |
|---|---|---|
| I-913 | April 30, 2029 | 001 |
| I-913 | April 30, 2029 | 002 |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 18 | Efficacy | Approved | April 30, 2026 | Priority |
| Supplement | 9 | Labeling | Approved | April 30, 2026 | Standard |
| Supplement | 16 | Labeling | Approved | November 5, 2025 | Standard |
| Supplement | 8 | Labeling | Approved | May 7, 2024 | Standard |
| Original application | 1 | Type 3 - New Dosage Form and Type 4 - New Combination | Approved | August 18, 2022 | Priority |
Review documents
- 0 · Supplement · May 12, 2026
- 0 · Supplement · May 12, 2026
- 0 · Supplement · May 6, 2026
- 0 · Supplement · May 4, 2026
- 0 · Supplement · May 1, 2026
- 0 · Supplement · November 6, 2025
- 0 · Supplement · November 6, 2025
- 0 · Supplement · November 6, 2025
- 0 · Original application · June 27, 2024
- 0 · Supplement · May 8, 2024
- 0 · Supplement · May 7, 2024
- 0 · Original application · August 29, 2022
- 0 · Original application · August 19, 2022
Adverse event reports
Source: openFDA FAERS109,679
FAERS reports mentioning this drug
A report count is not a risk measure. FAERS accepts voluntary and
mandatory reports without establishing causation, and reporting is influenced by how
widely a drug is used, how long it has been marketed, and media attention. FDA states
that reports “do not prove that the drug caused the event”. Compare rates, not totals.
Attributed to this product's most-reported active ingredient: BUPROPION HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 81968-030-22 | 81968-030 | Axsome Therapeutics, Inc. | 1 BOTTLE in 1 CARTON (81968-030-22) / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE | May 8, 2026 |
| 81968-045-14 | 81968-045 | Axsome Therapeutics, Inc. | 1 BOTTLE in 1 CARTON (81968-045-14) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE | September 18, 2024 |
| 81968-045-30 | 81968-045 | Axsome Therapeutics, Inc. | 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30) | August 18, 2022 |
| 81968-045-31 | 81968-045 | Axsome Therapeutics, Inc. | 1 BOTTLE in 1 CARTON (81968-045-31) / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE | May 10, 2024 |
| 81968-045-60 | 81968-045 | Axsome Therapeutics, Inc. | 60 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60) | June 28, 2024 |
| 81968-030 | 81968-030 | Axsome Therapeutics, Inc. | — | May 8, 2026 |
| 81968-045 | 81968-045 | Axsome Therapeutics, Inc. | — | August 18, 2022 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 12 sections on this page.