DrugDashboards

Naloxone Hydrochloride

Naloxone Hydrochloride · NALOXONE HYDROCHLORIDE 1 mg/mL · Injection, Solution · Intramuscular; Intravenous; Subcutaneous · Eugia US LLC

NDC 55150-0345-01 · 1 SYRINGE in 1 BOX / 2 mL in 1 SYRINGE · ANDA · View full market →

The short version

19 companies supply this market — deep enough that no single failure threatens the supply. One of its named manufacturing plants, Eugia Pharma Specialities Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want. 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

$0$2.50$5.00$7.50Aug 2026Sep 2026$6.28
1 price point · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$31.50
Reported to Texas DSHS · 2026 annual filing · Eugia Us Llc

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

Medicaid spend (2025)

$491
50 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

10Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • sterile injectable+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

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 →

Where it's made

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
ANDA213279
TE code
AP
Approval date
Jan 14, 2021
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, 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 — NDC 55150-0345-01," retrieved September 3, 2026, https://drugdashboards.com/drug/55150034501.

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