DrugDashboards

Naloxone Hydrochloride

Naloxone Hydrochloride · NALOXONE HYDROCHLORIDE .4 mg/mL · Injection · Intramuscular; Intravenous; Subcutaneous · Hikma Pharmaceuticals USA Inc.

NDC 00641-6193-10 · 10 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE · ANDA · View full market →

The short version

9 companies supply this market — a reasonable cushion if one runs into trouble. Historically, drugs in this position went on to a new shortage within 90 days about 0.4% of the time — roughly 3× the typical drug (0.1%).

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

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
$65.00
Reported to Texas DSHS · 2026 annual filing · Hikma Pharmaceuticals USA Inc.

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicare Part B (ASP)

Payment limit per 0.01 MG
$0.069
HCPCS J2312 · Jul 1, 2026 quarter · typically ASP + 6%

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.4%chance of a new FDA shortage posting for naloxone hydrochloride (injectable) in the next 90 days

sterile injectable · OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 3× that.

Backtested statistical model over the whole market, not this package alone. Model details →

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
ANDA212300
TE code
AP
Approval date
Jun 10, 2022
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 Naloxone Hydrochloride (Injection)

LabelerStrengthFirst seenLast seen
International Medication Systems, LimitedNALOXONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 3, 2026
Medical Purchasing Solutions, LLCNALOXONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 3, 2026
Dr. Reddy's Laboratories, Inc.NALOXONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Henry Schein, IncNALOXONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
HF Acquisition Co LLC, DBA HealthFirstNALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Sep 2, 2026
HF Acquisition Co. LLC, DBA HealthFirstNALOXONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.NALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.NALOXONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Par Health USA, LLCNALOXONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Remedyrepack Inc.NALOXONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
HF Acquisition Co LLC, DBA HealthFirstNALOXONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Aug 28, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Naloxone Hydrochloride — NDC 00641-6193-10," retrieved September 3, 2026, https://drugdashboards.com/drug/00641619310.

Free to cite with attribution — see how the data is put together.