DrugDashboards

Naloxone Hydrochloride

Naloxone Hydrochloride · NALOXONE HYDROCHLORIDE .4 mg/mL · Injection, Solution · Intramuscular; Intravenous; Subcutaneous · Fresenius Kabi USA, LLC

NDC 76045-0114-10 · 24 SYRINGE in 1 CARTON / 1 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. 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.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Medicare Part B pays (ASP+6%)$0.0690per billing unit (0.01 MG)HCPCS J2312 · Jul 1, 2026
  • Part D point of sale (median)$6.06per unitnegotiated price across 4,465 plans — before rebates · Apr 1, 2026
  • Federal contracts pay (FSS)$165.47per package of 24X1MLFresenius Kabi, LLC · May 15, 2025

Medicare Part D

All Part D pricing →
ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$6.06per unit
middle half $5.30$6.72 · 4,465 plans · Apr 1, 2026
Est. net of rebates
≈ $6.06
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
81%of plans cover it
tier 2 · prior auth 0% · step therapy 0% · qty limit 0%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 7 quarters since 2024.

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
$168.00
Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA

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 →

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 · median tier 2 across plans
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA213573
TE code
AP
Approval date
Apr 2, 2024
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 76045-0114-10," retrieved September 3, 2026, https://drugdashboards.com/drug/76045011410.

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