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.
Rezenopy
naloxone HCl · NALOXONE HYDROCHLORIDE 10 mg/.11mL · Spray · Nasal · Scienture LLC
NDC 83245-0003-01 · 2 BLISTER PACK in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .11 mL in 1 VIAL, SINGLE-DOSE · 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.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for naloxone hcl (other) 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
- Summit Biosciences Inc.United Statesanalysis · label · manufacture · pack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- NDA215487
- TE code
- —
- Approval date
- Apr 19, 2024
- Patents / exclusivity
- 2 patents, 1 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | NP | Apr 19, 2027 |
| patent | 12514854 | Feb 5, 2041 |
| patent | 12622903 | Feb 5, 2041 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of naloxone HCl (Spray)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| HF Acquisition Co LLC, DBA HealthFirst | NALOXONE HYDROCHLORIDE 4 mg/.1mL | Jul 15, 2026 | Sep 2, 2026 |
| Hikma Specialty USA Inc. | NALOXONE HYDROCHLORIDE 8 mg/.1mL | Jul 15, 2026 | Sep 2, 2026 |
| Scienture LLC | NALOXONE HYDROCHLORIDE 10 mg/.11mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Rezenopy — NDC 83245-0003-01," retrieved September 3, 2026, https://drugdashboards.com/drug/83245000301.
Free to cite with attribution — see how the data is put together.