DrugDashboards

Promethazine Hydrochloride

Promethazine Hydrochloride · PROMETHAZINE HYDROCHLORIDE 50 mg/mL · Injection, Solution · Intramuscular; Intravenous · XGen Pharmaceuticals DJB, Inc.

NDC 39822-5550-06 · 25 AMPULE in 1 CARTON / 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. The price has held steady around $2.34 per mL over the past year. It is in shortage right now — FDA lists the reason as “demand increase for the drug. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Pharmacies pay (NADAC)$2.34per MLinvoice-surveyed acquisition cost · May 20, 2026
  • Medicare Part B pays (ASP+6%)$3.64per billing unit (50 MG)HCPCS J2550 · Jul 1, 2026

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

$0$1.00$2.00$3.00Apr 2024Sep 2026$2.34
26 price points · per ML · held since Invalid DateSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$90.00
Reported to Texas DSHS · 2025 annual filing · Xgen Pharmaceuticals Djb

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

Medicare Part B (ASP)

Payment limit per 50 MG
$3.639
HCPCS J2550 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$759
44 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

45Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 3 active manufacturers+10
  • in shortage now+25
  • sterile injectable+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

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
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 39822-5550-06," retrieved September 3, 2026, https://drugdashboards.com/drug/39822555006.

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