DrugDashboards

Mitomycin

Mitomycin · MITOMYCIN 5 mg/10mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Bryant Ranch Prepack

NDC 72162-2464-02 · 1 VIAL in 1 CARTON / 10 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.

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.

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
ANDA202670
TE code
AP
Approval date
Oct 13, 2017
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 72162-2464-02," retrieved September 3, 2026, https://drugdashboards.com/drug/72162246402.

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