DrugDashboards

Haloperidol Decanoate

Haloperidol Decanoate · HALOPERIDOL DECANOATE 500 mg/5mL · Injection · Intramuscular · BluePoint Laboratories

NDC 68001-0582-41 · 1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE · ANDA · View full market →

The short version

16 companies supply this market — deep enough that no single failure threatens the supply. The price has fallen 38% in a year, to $13.33 per mL — and generics that get this cheap tend to get abandoned rather than defended. One of its named manufacturing plants, Somerset Therapeutics Private 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 0.5% 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.

  • Pharmacies pay (NADAC)$13.33per MLinvoice-surveyed acquisition cost · Sep 17, 2025
  • Medicare Part B pays (ASP+6%)$5.29per billing unit (50 MG)HCPCS J1631 · Jul 1, 2026
  • Part D plans paid (avg)$28.77per dosage unitgross, before rebates — matched by drug name · 2024

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$10.00$20.00$30.00Aug 2023Sep 2025$13.33
25 price points · per ML · last surveyed Invalid DateSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$200.00
Reported to Texas DSHS · 2025 annual filing · Blue Point Laboratories

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

Medicare Part B (ASP)

Payment limit per 50 MG
$5.291
HCPCS J1631 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2024)

$829
13 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)

0.5%chance of a new FDA shortage posting for haloperidol decanoate (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 · avg $48.63 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA209101
TE code
AO
Approval date
Jul 3, 2018
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation Haloperidol Decanoate, Injection, 50 mg/1 mL (NDC 63323-469-01)Jan 9, 2026
  • Planned discontinuation Haloperidol Decanoate, Injection, 50 mg/1 mL (NDC 63323-469-05)Jan 9, 2026

Recalls (this NDC)

  • Class II · OngoingApr 2, 2025
    Amerisource Health Services LLCLack of assurance of sterility. Bacterial contamination detected in some media fill units
  • Class II · OngoingApr 2, 2025
    Amerisource Health Services LLCLack of assurance of sterility. Bacterial contamination detected in some media fill units
  • Class II · OngoingApr 2, 2025
    Amerisource Health Services LLCLack of assurance of sterility. Bacterial contamination detected in some media fill units
  • Class II · OngoingMar 21, 2025
    Somerset Therapeutics Private LimitedLack of Assurance of Sterility: Media fill with bacterial contamination
  • Class II · OngoingMar 21, 2025
    Somerset Therapeutics Private LimitedLack of Assurance of Sterility: Media fill with bacterial contamination

Manufacturers of Haloperidol Decanoate (Injection)

LabelerStrengthFirst seenLast seen
BluePoint LaboratoriesHALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Sep 3, 2026
BluePoint LaboratoriesHALOPERIDOL DECANOATE 50 mg/mLJul 15, 2026Sep 3, 2026
Caplin Steriles LimitedHALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Sep 3, 2026
Remedyrepack Inc.HALOPERIDOL DECANOATE 50 mg/mLJul 15, 2026Sep 3, 2026
Somerset Therapeutics, LLCHALOPERIDOL DECANOATE 50 mg/mLJul 15, 2026Sep 3, 2026
Somerset Therapeutics, LLCHALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Sep 3, 2026
Zydus Lifesciences LimitedHALOPERIDOL DECANOATE 50 mg/mLJul 15, 2026Sep 3, 2026
Zydus Lifesciences LimitedHALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Sep 3, 2026
Armas Pharmaceuticals Inc.HALOPERIDOL DECANOATE 500 mg/5mLJul 15, 2026Sep 2, 2026
Armas Pharmaceuticals Inc.HALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Sep 2, 2026
Armas Pharmaceuticals Inc.HALOPERIDOL DECANOATE 50 mg/mLJul 15, 2026Sep 2, 2026
Caplin Steriles LimitedHALOPERIDOL DECANOATE 50 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCHALOPERIDOL DECANOATE 50 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedHALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedHALOPERIDOL DECANOATE 50 mg/mLJul 15, 2026Sep 2, 2026
Janssen Pharmaceuticals, Inc.HALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Sep 2, 2026
Janssen Pharmaceuticals, Inc.HALOPERIDOL DECANOATE 50 mg/mLJul 15, 2026Sep 2, 2026
Lifestar Pharma LLCHALOPERIDOL DECANOATE 500 mg/5mLJul 15, 2026Sep 2, 2026
Lifestar Pharma LLCHALOPERIDOL DECANOATE 250 mg/5mLJul 15, 2026Sep 2, 2026
Lifestar Pharma LLCHALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Sep 2, 2026
Lifestar Pharma LLCHALOPERIDOL DECANOATE 50 mg/mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.HALOPERIDOL DECANOATE 50 mg/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCHALOPERIDOL DECANOATE 50 mg/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCHALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Sep 2, 2026
NorthStar RxLLCHALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Sep 2, 2026
Patriot Pharmaceuticals LLCHALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Sep 2, 2026
Patriot Pharmaceuticals LLCHALOPERIDOL DECANOATE 50 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCHALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Aug 31, 2026
Hikma Pharmaceuticals USA Inc.HALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Aug 31, 2026
Meitheal Pharmaceuticals Inc.HALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Aug 31, 2026
Remedyrepack Inc.HALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Aug 31, 2026
Zydus Pharmaceuticals USA Inc.HALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Aug 31, 2026
Zydus Pharmaceuticals USA Inc.HALOPERIDOL DECANOATE 50 mg/mLJul 15, 2026Aug 31, 2026
BluePoint LaboratoriesHALOPERIDOL DECANOATE 500 mg/5mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Haloperidol Decanoate — NDC 68001-0582-41," retrieved September 3, 2026, https://drugdashboards.com/drug/68001058241.

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