The short version
12 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.
regadenoson
regadenoson · REGADENOSON .08 mg/mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC 36000-0364-01 · 1 SYRINGE, PLASTIC in 1 CARTON / 5 mL in 1 SYRINGE, PLASTIC · ANDA · View full market →
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
$25.00
Reported to Texas DSHS · 2026 annual filing · Baxter Healthcare Corporation
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 0.1 MG
$2.790
HCPCS J2785 · Jul 1, 2026 quarter · typically ASP + 6%
Medicaid spend (2025)
$4,436
413 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Gland Pharma LimitedIndiaanalysis · label · manufacture · pack
- Simtra US LLCUnited Statesanalysis · label · manufacture · pack · sterilize
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
- ANDA217455
- TE code
- AP
- Approval date
- May 23, 2023
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class II · OngoingOct 30, 2024Baxter Healthcare Corporation — Labeling: Missing Label
Manufacturers of regadenoson (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Apotex Corp. | REGADENOSON .08 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Accord Healthcare Inc. | REGADENOSON .08 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Astellas Pharma US, Inc. | REGADENOSON .08 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Baxter Healthcare Corporation | REGADENOSON .08 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Gland Pharma Limited | REGADENOSON .08 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Hikma Pharmaceuticals USA Inc. | REGADENOSON ANHYDROUS .08 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Hospira, Inc. | REGADENOSON ANHYDROUS .08 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Indies Pharma Jamaica Limited | REGADENOSON .08 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| International Medication Systems, Limited | REGADENOSON ANHYDROUS .08 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Kanchan Healthcare Inc | REGADENOSON .08 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Marlex Pharmaceuticals, Inc. | REGADENOSON .08 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Meitheal Pharmaceuticals Inc. | REGADENOSON .08 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "regadenoson — NDC 36000-0364-01," retrieved September 3, 2026, https://drugdashboards.com/drug/36000036401.
Free to cite with attribution — see how the data is put together.