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Haloperidol Decanoate

Haloperidol Decanoate · HALOPERIDOL DECANOATE 250 mg/5mL · Injection · Intramuscular · Lifestar Pharma LLC

NDC 70756-0624-10 · 10 VIAL in 1 CARTON / 5 mL in 1 VIAL · 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

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

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
ANDA216730
TE code
AO
Approval date
May 23, 2023
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 70756-0624-10," retrieved September 3, 2026, https://drugdashboards.com/drug/70756062410.

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