DrugDashboards

Promethazine Hydrochloride

Promethazine Hydrochloride · PROMETHAZINE HYDROCHLORIDE 25 mg/mL · Injection, Solution · Intramuscular; Intravenous · ProPharma Distribution

NDC 84549-0525-03 · 1 mL in 1 AMPULE · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. It is in shortage right now — FDA lists the reason as “demand increase for the drug”.

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)

0.4%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 →

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
ANDA040737
TE code
AP
Approval date
Apr 24, 2008
Patents / exclusivity
None on file

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 84549-0525-03," retrieved September 3, 2026, https://drugdashboards.com/drug/84549052503.

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