DrugDashboards

Haloperidol Decanoate

Haloperidol Decanoate · HALOPERIDOL DECANOATE 50 mg/mL · Injection · Intramuscular · Remedyrepack Inc.

NDC 70518-3743-00 · 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. 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.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 67457-0410-13) — 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ⓘ
$15.70per unit
middle half $12.88–$17.48 · 5,496 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $15.70
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 10 quarters since 2024.

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

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
ANDA214507
TE code
AO
Approval date
Jul 26, 2021
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 70518-3743-00," retrieved September 3, 2026, https://drugdashboards.com/drug/70518374300.

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