DrugDashboards

Chlorpromazine Hydrochloride

Chlorpromazine Hydrochloride · CHLORPROMAZINE HYDROCHLORIDE 25 mg/mL · Injection · Intramuscular · Fresenius Kabi USA, LLC

NDC 65219-0130-02 · 25 VIAL in 1 CARTON / 2 mL in 1 VIAL · ANDA · View full market →

The short version

11 companies supply this market — deep enough that no single failure threatens the supply. One of its named manufacturing plants, Immacule Lifesciences Private Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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.

Estimated fill cost

WAC per package, as filed
$499.75
Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA

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

Medicare Part B (ASP)

Payment limit per 50 MG
$18.143
HCPCS J3230 · Jul 1, 2026 quarter · typically ASP + 6%

Supply fragility

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

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
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA216724
TE code
AP
Approval date
Dec 10, 2024
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 Chlorpromazine Hydrochloride (Injection)

LabelerStrengthFirst seenLast seen
Camber Pharmaceuticals, Inc.CHLORPROMAZINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Sep 3, 2026
Devatis, Inc.CHLORPROMAZINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Sep 3, 2026
Fresenius Kabi USA, LLCCHLORPROMAZINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Sep 3, 2026
Novadoz Pharmaceuticals LLCCHLORPROMAZINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Sep 3, 2026
Piramal Critical Care Inc.CHLORPROMAZINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Sep 3, 2026
Zydus Lifesciences LimitedCHLORPROMAZINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Sep 3, 2026
Zydus Pharmaceuticals USA Inc.CHLORPROMAZINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Sep 3, 2026
Henry Schein, Inc.CHLORPROMAZINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Sep 2, 2026
Eugia US LLCCHLORPROMAZINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Aug 31, 2026
Gland Pharma LimitedCHLORPROMAZINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Aug 31, 2026
Hikma Pharmaceuticals USA Inc.CHLORPROMAZINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Chlorpromazine Hydrochloride — NDC 65219-0130-02," retrieved September 3, 2026, https://drugdashboards.com/drug/65219013002.

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