DrugDashboards

Azacitidine

Azacitidine · AZACITIDINE 100 mg/1 · Injection, Powder, Lyophilized, For Solution · Intravenous; Subcutaneous · Somerset Therapeutics LLC

NDC 70069-0857-01 · 1 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS · ANDA · View full market →

The short version

20 companies supply this market — deep enough that no single failure threatens the supply. It is in shortage right now — FDA lists the reason as “other”. One of its named manufacturing plants, Reliance Life Sciences Private Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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
$45.00
Reported to Texas DSHS · 2026 annual filing · Somerset Therapeutics, LLC

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

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 $1,839.38 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA217453
TE code
AP
Approval date
May 20, 2025
Patents / exclusivity
None on file

Shortage history

  • In shortage now — Azacitidine, Injection, 100 mg (NDC 68001-313-56)Dec 22, 2020
    Other
    month 69 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now — Azacitidine, Injection, 100 mg/4 mL (NDC 55150-393-01)Dec 22, 2020
    Demand increase for the drug
    month 69 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now — Azacitidine, Injection, 100 mg (NDC 16729-306-10)Dec 21, 2020
    month 69 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now — Azacitidine, Injection, 100 mg (NDC 43598-305-62)Dec 18, 2020
    month 69 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now — Azacitidine, Injection, 100 mg (NDC 72485-201-01)Dec 18, 2020
    Other
    month 69 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now — Azacitidine, Injection, 100 mg/ Vial (NDC 0143-9606-01)Dec 18, 2020
    month 69 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now — Azacitidine, Injection, 100 mg/30 mL (NDC 63323-771-39)Dec 18, 2020
    Discontinuation of the manufacture of the drug
    month 69 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now — Azacitidine, Injection, 100 mg/30 mL (NDC 71288-115-30)Dec 18, 2020
    month 69 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months
  • In shortage now — Vidaza, Injection, 100 mg (NDC 59572-102-01)Dec 18, 2020
    month 69 — 3× the typical 20-month injectable shortage · model puts 28% odds it resolves within 6 months

Recalls (this NDC)

No enforcement reports list this package NDC.

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

LabelerStrengthFirst seenLast seen
BluePoint LaboratoriesAZACITIDINE 100 mg/1Jul 15, 2026Sep 3, 2026
Dr. Reddy's Laboratories Inc.AZACITIDINE 100 mg/1Jul 15, 2026Sep 3, 2026
Accord Healthcare Inc.AZACITIDINE 100 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCAZACITIDINE 100 mg/1Jul 15, 2026Sep 2, 2026
Apotex CorpAZACITIDINE 100 mg/1Jul 15, 2026Sep 2, 2026
Armas Pharmaceuticals Inc.AZACITIDINE 100 mg/1Jul 15, 2026Sep 2, 2026
BluePoint Laboratories.AZACITIDINE 100 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.AZACITIDINE 100 mg/1Jul 15, 2026Sep 2, 2026
Celgene CorporationAZACITIDINE 100 mg/1Jul 15, 2026Sep 2, 2026
Civica, Inc.AZACITIDINE 100 mg/1Jul 15, 2026Sep 2, 2026
Eugia US LLCAZACITIDINE 100 mg/4mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCAZACITIDINE 100 mg/30mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.AZACITIDINE 100 mg/1Jul 15, 2026Sep 2, 2026
Msn Laboratories Private LimitedAZACITIDINE 100 mg/1Jul 15, 2026Sep 2, 2026
NorthStar RxLLCAZACITIDINE 100 mg/1Jul 15, 2026Sep 2, 2026
Panacea Biotec LimitedAZACITIDINE 100 mg/50mLJul 15, 2026Sep 2, 2026
Reliance Life Sciences Private LimitedAZACITIDINE 100 mg/1Jul 15, 2026Sep 2, 2026
Sandoz IncAZACITIDINE 100 mg/1Jul 15, 2026Sep 2, 2026
Somerset Therapeutics LLCAZACITIDINE 100 mg/1Jul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.AZACITIDINE 100 mg/1Jul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Azacitidine — NDC 70069-0857-01," retrieved September 3, 2026, https://drugdashboards.com/drug/70069085701.

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