DrugDashboards

Decitabine

decitabine · DECITABINE 50 mg/20mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Qilu Pharmaceutical Co., Ltd.

NDC 67184-0535-01 · 1 VIAL in 1 CARTON / 20 mL in 1 VIAL · ANDA · View full market →

The short version

17 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 $1,183.24 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA212826
TE code
AP
Approval date
Apr 12, 2021
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation Decitabine, Injection, 50 mg (NDC 68001-573-41)Feb 20, 2026

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of decitabine (Injection, Powder, Lyophilized, For Solution)

LabelerStrengthFirst seenLast seen
Meitheal Pharmaceuticals Inc.DECITABINE 50 mg/20mLJul 15, 2026Sep 3, 2026
Novadoz Pharmaceuticals LLCDECITABINE 50 mg/10mLJul 15, 2026Sep 3, 2026
Accord Healthcare Inc.DECITABINE 50 mg/20mLJul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCDECITABINE 50 mg/20mLJul 15, 2026Sep 2, 2026
BluePoint LaboratoriesDECITABINE 50 mg/20mLJul 15, 2026Sep 2, 2026
BluePoint LaboratoriesDECITABINE 50 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesDECITABINE 50 mg/10mLJul 15, 2026Sep 2, 2026
Bryant Ranch PrepackDECITABINE 50 mg/10mLJul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.DECITABINE 50 mg/10mLJul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories Inc.DECITABINE 50 mg/10mLJul 15, 2026Sep 2, 2026
Dr.Reddy's Laboratories LimitedDECITABINE 50 mg/10mLJul 15, 2026Sep 2, 2026
Eugia US LLCDECITABINE 50 mg/26mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedDECITABINE 50 mg/10mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.DECITABINE 50 mg/1Jul 15, 2026Sep 2, 2026
Mylan Institutional LLCDECITABINE 50 mg/20mLJul 15, 2026Sep 2, 2026
Nivagen Pharmaceuticals, Inc.DECITABINE 50 mg/20mLJul 15, 2026Sep 2, 2026
Northstar Rx LLCDECITABINE 50 mg/10mLJul 15, 2026Sep 2, 2026
Qilu Pharmaceutical Co., Ltd.DECITABINE 50 mg/20mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsDECITABINE 50 mg/20mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Decitabine — NDC 67184-0535-01," retrieved September 3, 2026, https://drugdashboards.com/drug/67184053501.

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