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.
Naloxone Hydrochloride
Nalxone Hydrochloride · NALOXONE HYDROCHLORIDE .4 mg/mL · Injection · Intramuscular; Intravenous; Subcutaneous · Hikma Pharmaceuticals USA Inc.
NDC 00641-6260-25 · 25 VIAL in 1 CARTON / 1 mL in 1 VIAL · 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.
Where it's made
- Hikma Pharmaceuticals USA Inc.United Statesanalysis · label · manufacture · pack
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
- ANDA070299
- TE code
- AP
- Approval date
- Sep 24, 1986
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Nalxone Hydrochloride (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | NALOXONE HYDROCHLORIDE .4 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Civica, Inc. | NALOXONE HYDROCHLORIDE .4 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Medical Purchasing Solutions, LLC | NALOXONE HYDROCHLORIDE .4 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Naloxone Hydrochloride — NDC 00641-6260-25," retrieved September 3, 2026, https://drugdashboards.com/drug/00641626025.
Free to cite with attribution — see how the data is put together.