The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Auvelity
dextromethorphan hydrobromide, bupropion hydrochloride · Kit · Axsome Therapeutics, Inc.
NDC 81968-0453-01 · 1 KIT in 1 KIT * 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 · NDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $1,054.69 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA215430
- TE code
- —
- Approval date
- Aug 18, 2022
- Patents / exclusivity
- 204 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | I-913 | Apr 30, 2029 |
| exclusivity | I-913 | Apr 30, 2029 |
| patent | 12653795 | Nov 28, 2043 |
| patent | 12194036 | Apr 20, 2043 |
| patent | 11844797 | Apr 20, 2043 |
| patent | 11839612 | Mar 2, 2043 |
| patent | 12042473 | Feb 23, 2043 |
| patent | 12146889 | Feb 23, 2043 |
| patent | 11752144 | Feb 23, 2043 |
| patent | 12472155 | Feb 23, 2043 |
| patent | 11986444 | Feb 15, 2043 |
| patent | 12370154 | Feb 15, 2043 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of dextromethorphan hydrobromide, bupropion hydrochloride (Kit)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Axsome Therapeutics, Inc. | Jul 15, 2026 | Sep 3, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Auvelity — NDC 81968-0453-01," retrieved September 3, 2026, https://drugdashboards.com/drug/81968045301.
Free to cite with attribution — see how the data is put together.