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.
Fexinidazole
Fexinidazole · FEXINIDAZOLE 600 mg/1 · Tablet · Oral · Sanofi-Aventis U.S. LLC
NDC 00024-4512-14 · 14 TABLET in 1 DOSE PACK · 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.
Where it's made
- Alcami Carolinas CorporationUnited Stateslabel · pack
- Alcami Carolinas CorporationUnited Statesanalysis
- Alcami Carolinas CorporationUnited Statesmanufacture
- EUROAPI Hungary Ltd.Hungaryanalysis · api 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
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA214429
- TE code
- —
- Approval date
- Jul 16, 2021
- Patents / exclusivity
- 0 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | ODE-359 | Jul 16, 2028 |
| exclusivity | NCE | Jul 16, 2026 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Fexinidazole (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Sanofi-Aventis U.S. LLC | FEXINIDAZOLE 600 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, "Fexinidazole — NDC 00024-4512-14," retrieved September 3, 2026, https://drugdashboards.com/drug/00024451214.
Free to cite with attribution — see how the data is put together.