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haloperidol decanoate

haloperidol decanoate · HALOPERIDOL DECANOATE 50 mg/mL · Injection, Solution · Intramuscular · Sagent Pharmaceuticals

NDC 25021-0831-01 · 10 VIAL in 1 CARTON / 1 mL in 1 VIAL · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. The price has fallen 41% in a year, to $6.74 per mL — and generics that get this cheap tend to get abandoned rather than defended. Put together: this is a fragile supply — if anything else goes wrong, there is very little slack to absorb it. 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)$6.74per 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

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$30.00Mar 2018Sep 2026$6.74
32 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$200.00
Reported to Texas DSHS · 2026 annual filing · Sagent Pharmaceuticals

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 (2023)

$13,146
430 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

55High risk

Several kinds of pressure are visible at once — each line below is a condition that historically precedes supply trouble, and this market is stacking them.

  • 1 active manufacturer+30
  • price down 42% year over year+15
  • 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 →

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
ANDA205241
TE code
AO
Approval date
May 12, 2017
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 haloperidol decanoate (Injection, Solution)

LabelerStrengthFirst seenLast seen
Sagent PharmaceuticalsHALOPERIDOL DECANOATE 100 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsHALOPERIDOL DECANOATE 50 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsHALOPERIDOL DECANOATE 500 mg/5mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "haloperidol decanoate — NDC 25021-0831-01," retrieved September 3, 2026, https://drugdashboards.com/drug/25021083101.

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