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Azacitidine

Azacitidine · AZACITIDINE 1 kg/kg · Powder · Hetero Labs Limited

NDC 68554-0104-01 · 7.1 kg in 1 DRUM · BULK INGREDIENT · View full market →

Bulk ingredient — not a finished product

This NDC is a raw material (bulk ingredient) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.

Medicare Part D

This is a bulk ingredient, not a dispensable product — it is a raw material sold to manufacturers and compounders, so no plan prices it.

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.

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 · avg $16,598.29 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
TE code
Approval date
Patents / exclusivity

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Azacitidine (Powder)

LabelerStrengthFirst seenLast seen
Aurobindo Pharma LimitedAZACITIDINE 50 kg/50kgJul 15, 2026Sep 2, 2026
Hetero Labs LimitedAZACITIDINE 1 kg/kgJul 15, 2026Sep 2, 2026
Huzhou Zhanwang Pharmaceutical Co. LtdAZACITIDINE 1 g/gJul 15, 2026Sep 2, 2026
Jiangsu Hansoh Pharmaceutical Group Co., Ltd.AZACITIDINE 1 g/gJul 15, 2026Sep 2, 2026
MSN Laboratories Private LimitedAZACITIDINE 1 kg/kgJul 15, 2026Sep 2, 2026
Olon S.p.A.AZACITIDINE 1 kg/kgJul 15, 2026Sep 2, 2026
ScinoPharm Taiwan Ltd.AZACITIDINE 1 kg/kgJul 15, 2026Sep 2, 2026
Shilpa Pharma Lifesciences LimitedAZACITIDINE 1 kg/kgJul 15, 2026Sep 2, 2026
Sicor de Mexico S.A. de C.VAZACITIDINE 100 kg/100kgJul 15, 2026Sep 2, 2026
Sicor S.r.l.AZACITIDINE 1 kg/kgJul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.AZACITIDINE 25 kg/25kgJul 15, 2026Sep 2, 2026
Valary Lab Private LimitedAZACITIDINE 1 kg/kgJul 15, 2026Sep 2, 2026
Wuhan Biocause Pharmaceutical Development Co., LtdAZACITIDINE 100 g/100gJul 15, 2026Sep 2, 2026
Laurus Labs LimitedAZACITIDINE 1 kg/kgJul 15, 2026Aug 28, 2026
Shanghai Huilun Jiangsu Pharmaceutical Co., Ltd.AZACITIDINE 1 kg/kgJul 15, 2026Jul 29, 2026

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

Cite this page

DrugDashboards, "Azacitidine — NDC 68554-0104-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68554010401.

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