DrugDashboards

Mitomycin

Mitomycin · MITOMYCIN 5 mg/10mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Eugia US LLC

NDC 55150-0450-01 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

11 companies supply this market — deep enough that no single failure threatens the supply.

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.

  • Medicare Part B pays (ASP+6%)$34.11per billing unit (5 MG)HCPCS J9280 · Jul 1, 2026
  • Part D plans paid (avg)$500.70per dosage unitgross, before rebates — matched by drug name · 2024

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
$150.00
Reported to Texas DSHS · 2026 annual filing · Eugia Us Llc

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

Medicare Part B (ASP)

Payment limit per 5 MG
$34.107
HCPCS J9280 · 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 2 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $1,426.91 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA216732
TE code
—
Approval date
Oct 30, 2023
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 Mitomycin (Injection, Powder, Lyophilized, For Solution)

LabelerStrengthFirst seenLast seen
BluePoint LaboratoriesMITOMYCIN 40 mg/80mLJul 15, 2026Sep 3, 2026
BluePoint LaboratoriesMITOMYCIN 5 mg/10mLJul 15, 2026Sep 3, 2026
Accord BioPharma Inc.MITOMYCIN 40 mg/80mLJul 15, 2026Sep 2, 2026
Accord BioPharma Inc.MITOMYCIN 5 mg/10mLJul 15, 2026Sep 2, 2026
Accord Healthcare, Inc.MITOMYCIN 5 mg/10mLJul 15, 2026Sep 2, 2026
Accord Healthcare, Inc.MITOMYCIN 20 mg/40mLJul 15, 2026Sep 2, 2026
Accord Healthcare, Inc.MITOMYCIN 40 mg/80mLJul 15, 2026Sep 2, 2026
Archis Pharma LLCMITOMYCIN 40 mg/80mLJul 15, 2026Sep 2, 2026
Archis Pharma LLCMITOMYCIN 20 mg/40mLJul 15, 2026Sep 2, 2026
Eugia US LLCMITOMYCIN 5 mg/10mLJul 15, 2026Sep 2, 2026
Eugia US LLCMITOMYCIN 20 mg/40mLJul 15, 2026Sep 2, 2026
Eugia US LLCMITOMYCIN 40 mg/80mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCMITOMYCIN 20 mg/40mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCMITOMYCIN 40 mg/80mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCMITOMYCIN 5 mg/10mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedMITOMYCIN 5 mg/10mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedMITOMYCIN 20 mg/40mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedMITOMYCIN 40 mg/80mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.MITOMYCIN 20 mg/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.MITOMYCIN 20 mg/40mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.MITOMYCIN 40 mg/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.MITOMYCIN 40 mg/80mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.MITOMYCIN 40 mg/80mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.MITOMYCIN 5 mg/10mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.MITOMYCIN 20 mg/40mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsMITOMYCIN 5 mg/10mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsMITOMYCIN 40 mg/80mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsMITOMYCIN 20 mg/40mLJul 15, 2026Sep 2, 2026
Archis Pharma LLCMITOMYCIN 5 mg/10mLJul 15, 2026Aug 31, 2026
Bryant Ranch PrepackMITOMYCIN 5 mg/10mLJul 15, 2026Aug 31, 2026
BluePoint LaboratoriesMITOMYCIN 20 mg/40mLJul 15, 2026Aug 29, 2026

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

Cite this page

DrugDashboards, "Mitomycin — NDC 55150-0450-01," retrieved September 3, 2026, https://drugdashboards.com/drug/55150045001.

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