DrugDashboards

Naloxone Hydrochloride Injection, USP, Auto-Injector

Naloxone Hydrochloride · NALOXONE HYDROCHLORIDE 10 mg/.4mL · Injection, Solution · Intramuscular; Subcutaneous · Kaleo, Inc.

NDC 60842-0002-02 · 10 DOSE PACK in 1 CARTON / .4 mL in 1 DOSE PACK · NDA · View full market →

The short version

19 companies supply this market — deep enough that no single failure threatens the supply. 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
$1,800.00
Reported to Texas DSHS · 2025 annual filing · Kaleo Inc.

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

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
NDA215457
TE code
—
Approval date
Feb 28, 2022
Patents / exclusivity
6 patents, 0 exclusivities
TypeNumber / codeExpires
patent10143792May 24, 2031
patent10322239Feb 28, 2031
patent9474869Feb 28, 2031
patent8939943Feb 28, 2031
patent9022022Feb 28, 2031
patent9814838Feb 28, 2031

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, Solution)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsNALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Sep 3, 2026
Eugia US LLCNALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Sep 3, 2026
Henry Schein, Inc.NALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Sep 3, 2026
HF Acquisition Co LLC, DBA HealthFirstNALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Sep 3, 2026
Hospira, Inc.NALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Sep 3, 2026
Medical Purchasing Solutions, LLCNALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Sep 3, 2026
Mylan Institutional LLCNALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Sep 3, 2026
ProPharma DistributionNALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Sep 3, 2026
Somerset Therapeutics, LLCNALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Sep 3, 2026
Baxter Healthcare CorporationNALOXONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
BPI Labs LLCNALOXONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Eugia US LLCNALOXONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCNALOXONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCNALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Sep 2, 2026
HF Acquisition Co LLC, DBA HealthFirstNALOXONE 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 .4 mg/mLJul 15, 2026Sep 2, 2026
Kaleo, Inc.NALOXONE HYDROCHLORIDE 10 mg/.4mLJul 15, 2026Sep 2, 2026
Medical Purchasing Solutions, LLCNALOXONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCNALOXONE HYDROCHLORIDE 1 mg/mLJul 15, 2026Sep 2, 2026
NorthStar RxLLCNALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Sep 2, 2026
Sina Health IncNALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Sep 2, 2026
ZMI Pharma Inc.NALOXONE HYDROCHLORIDE 5 mg/.5mLJul 15, 2026Sep 2, 2026
Lifestar Pharma LLCNALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Aug 31, 2026
Baxter Healthcare CorporationNALOXONE HYDROCHLORIDE .4 mg/mLJul 15, 2026Aug 29, 2026

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

Cite this page

DrugDashboards, "Naloxone Hydrochloride Injection, USP, Auto-Injector — NDC 60842-0002-02," retrieved September 3, 2026, https://drugdashboards.com/drug/60842000202.

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