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.
RoxyBond
Oxycodone hydrochloride · OXYCODONE HYDROCHLORIDE 10 mg/1 · Tablet, Coated · Oral · Protega Pharmaceuticals Inc
NDC 81140-0104-10 · 100 TABLET, COATED 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.
Estimated fill cost
WAC per package, as filed
$1,813.49
Reported to Texas DSHS · 2026 annual filing · Protega Pharmaceuticals
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicaid spend (2025)
$1.2M
698 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.2%chance of a new FDA shortage posting for oxycodone hydrochloride (oral solid) in the next 90 days
OAI inspection at a producing facility (24 months) · sole-source market · 1 Class I/II recall(s) in 12 months
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
- Galephar Pharmaceutical Research IncPuerto Ricomanufacture
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 2 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $1,657.56 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program · Opioid Analgesic REMS Shared System REMS
Regulatory
- Application
- NDA209777
- TE code
- —
- Approval date
- Apr 20, 2017
- Patents / exclusivity
- 8 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 7955619 | Aug 12, 2028 |
| patent | 10314788 | Aug 12, 2028 |
| patent | 7955619 | Aug 12, 2028 |
| patent | 10314788 | Aug 12, 2028 |
| patent | 7955619 | Aug 12, 2028 |
| patent | 7955619 | Aug 12, 2028 |
| patent | 10314788 | Aug 12, 2028 |
| patent | 10314788 | Aug 12, 2028 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Oxycodone hydrochloride (Tablet, Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Protega Pharmaceuticals Inc | OXYCODONE HYDROCHLORIDE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Protega Pharmaceuticals Inc | OXYCODONE HYDROCHLORIDE 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Protega Pharmaceuticals Inc | OXYCODONE HYDROCHLORIDE 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Protega Pharmaceuticals Inc | OXYCODONE HYDROCHLORIDE 5 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, "RoxyBond — NDC 81140-0104-10," retrieved September 3, 2026, https://drugdashboards.com/drug/81140010410.
Free to cite with attribution — see how the data is put together.