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Promethazine Hydrochloride

Promethazine Hydrochloride · PROMETHAZINE HYDROCHLORIDE 25 mg/mL · Injection, Solution · Solupharm Pharmazeutische Erzeugnisse GmbH

NDC 55579-0401-25 · 25 AMPULE in 1 CARTON / 1 mL in 1 AMPULE · DRUG FOR FURTHER PROCESSING · View full market →

Bulk ingredient — not a finished product

This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.

Medicare Part D

This is a bulk ingredient, not a dispensable product — it is a raw material sold to manufacturers and compounders, so no plan prices it.

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)

0.4%chance of a new FDA shortage posting for promethazine hydrochloride (injectable) in the next 90 days

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

Regulatory

Application
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TE code
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Approval date
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Patents / exclusivity
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Shortage history

  • In shortage now — Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 39822-5525-3)Nov 21, 2023
    month 34 of a typical 20 for injectable shortages · model puts 34% odds it resolves within 6 months
  • In shortage now — Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 39822-5550-6)Nov 21, 2023
    Demand increase for the drug
    month 34 of a typical 20 for injectable shortages · model puts 34% odds it resolves within 6 months

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Promethazine Hydrochloride (Injection, Solution)

LabelerStrengthFirst seenLast seen
ProPharma DistributionPROMETHAZINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Sep 2, 2026
Solupharm Pharmazeutische Erzeugnisse GmbHPROMETHAZINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Sep 2, 2026
Solupharm Pharmazeutische Erzeugnisse GmbHPROMETHAZINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
XGen Pharmaceuticals DJB, Inc.PROMETHAZINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Sep 2, 2026
XGen Pharmaceuticals DJB, Inc.PROMETHAZINE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Promethazine Hydrochloride — NDC 55579-0401-25," retrieved September 3, 2026, https://drugdashboards.com/drug/55579040125.

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