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Regadenoson

Regadenoson · REGADENOSON .08 mg/mL · Injection, Solution · Intravenous · Indies Pharma Jamaica Limited

NDC 83032-0001-02 · 1 SYRINGE in 1 CARTON / 5 mL in 1 SYRINGE · ANDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply. One of its named manufacturing plants, Abryl Laboratories 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.

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 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA218054
TE code
AP
Approval date
Aug 22, 2024
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 Regadenoson (Injection, Solution)

LabelerStrengthFirst seenLast seen
Apotex Corp.REGADENOSON .08 mg/mLJul 15, 2026Sep 3, 2026
Accord Healthcare Inc.REGADENOSON .08 mg/mLJul 15, 2026Sep 2, 2026
Astellas Pharma US, Inc.REGADENOSON .08 mg/mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationREGADENOSON .08 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedREGADENOSON .08 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.REGADENOSON ANHYDROUS .08 mg/mLJul 15, 2026Sep 2, 2026
Hospira, Inc.REGADENOSON ANHYDROUS .08 mg/mLJul 15, 2026Sep 2, 2026
Indies Pharma Jamaica LimitedREGADENOSON .08 mg/mLJul 15, 2026Sep 2, 2026
International Medication Systems, LimitedREGADENOSON ANHYDROUS .08 mg/mLJul 15, 2026Sep 2, 2026
Kanchan Healthcare IncREGADENOSON .08 mg/mLJul 15, 2026Sep 2, 2026
Marlex Pharmaceuticals, Inc.REGADENOSON .08 mg/mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.REGADENOSON .08 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Regadenoson — NDC 83032-0001-02," retrieved September 3, 2026, https://drugdashboards.com/drug/83032000102.

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