DrugDashboards

Haloperidol Decanoate

Haloperidol Decanoate · HALOPERIDOL DECANOATE 100 mg/mL · Injection · Intramuscular · Caplin Steriles Limited

NDC 65145-0167-10 · 10 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

16 companies supply this market — deep enough that no single failure threatens the supply. 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)$7.44per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • 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

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 67457-0409-13) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ 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
$23.49per unit
middle half $19.58$26.55 · 5,478 plans · Apr 1, 2026
Est. net of rebates
≈ $23.49
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 4 · prior auth 5% · 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 9 quarters since 2024.

NADAC price per unit

$0$5.00$10.00Mar 2026Sep 2026$7.44
7 price points · per MLSource: CMS NADAC

Medicare Part B (ASP)

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

Medicaid spend (2026 YTD · Q1)

$1,092
49 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
ANDA219168
TE code
AO
Approval date
May 13, 2025
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)

No enforcement reports list this package NDC.

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 65145-0167-10," retrieved September 3, 2026, https://drugdashboards.com/drug/65145016710.

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