The short version
Just 3 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Asenapine
Asenapine · ASENAPINE 10 mg/1 · Tablet · Sublingual · Sigmapharm Laboratories, LLC
NDC 42794-0017-22 · 10 TABLET in 1 BOTTLE, PLASTIC · ANDA · 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.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for asenapine (oral solid) in the next 90 days
sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Where it's made
- Sigmapharm Laboratories, LLCUnited Statesanalysis · manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
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 $1,353.12 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA206107
- TE code
- AB
- Approval date
- Dec 10, 2020
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class III · TerminatedApr 19, 2021SigmaPharm Laboratories LLC — Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
- Class III · TerminatedApr 19, 2021SigmaPharm Laboratories LLC — Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Manufacturers of Asenapine (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Alembic Pharmaceuticals Inc. | ASENAPINE 2.5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Inc. | ASENAPINE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Inc. | ASENAPINE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | ASENAPINE 2.5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | ASENAPINE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | ASENAPINE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sigmapharm Laboratories, LLC | ASENAPINE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sigmapharm Laboratories, LLC | ASENAPINE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Asenapine — NDC 42794-0017-22," retrieved September 3, 2026, https://drugdashboards.com/drug/42794001722.
Free to cite with attribution — see how the data is put together.