Pharmacologic Cardiac Stress Test Agent, Adenosine Receptor Agonist
Where is Regadenoson made?
15 companies sell it under their own name and 1 repackager rebottle it. Their labels name 7 factories in India and the United States.
India 4United States 3
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation0.08 mg per 1 mL · NDC 36000-364 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Simtra US LLCMakes it, tests it, packages it, labels it and sterilizes it | Bloomington, IN, United States | Problems found, fixed voluntarilySep 2024 | |
| Dr. Reddy's Laboratories Inc.0.08 mg per 1 mL · NDC 43598-616 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Gland Pharma LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 | |
| AuroMedics Pharma LLC0.08 mg per 1 mL · NDC 55150-443 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Gland Pharma Limited0.08 mg per 1 mL · NDC 68083-175 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Hospira, Inc.0.08 mg per 1 mL · NDC 0409-1401 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Indies Pharma Jamaica Limited0.08 mg per 1 mL · NDC 83032-001 | Abryl Laboratories Private LimitedMakes it | District Sas Nagar, India | Serious problems, FDA actionSep 2025 |
| International Medication Systems, Ltd.0.08 mg per 1 mL · NDC 76329-3321 | International Medication Systems, Ltd.Makes it, makes the active ingredient and tests it | South El Monte, CA, United States | Serious problems, FDA actionDec 2025 |
| Kanchan Healthcare Inc0.08 mg per 1 mL · NDC 85742-012 | Abryl Laboratories Private LimitedMakes it | District Sas Nagar, India | Serious problems, FDA actionSep 2025 |
| Marlex Pharmaceuticals, Inc.0.08 mg per 1 mL · NDC 10135-803 | Abryl Laboratories Private LimitedMakes it | District Sas Nagar, India | Serious problems, FDA actionSep 2025 |
| Accord Healthcare Inc.0.08 mg/mL · NDC 16729-477 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Almaject, Inc.0.08 mg per 1 mL · NDC 72611-874 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.0.08 mg per 1 mL · NDC 60505-6288, 60505-6116 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Astellas Pharma US, Inc. Lexiscan0.08 mg per 1 mL · NDC 0469-6501 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.0.08 mg per 1 mL · NDC 0641-6253 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Meitheal Pharmaceuticals Inc.0.08 mg per 1 mL · NDC 71288-201 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Regadenoson in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- HF Acquisition Co. LLC. DBA HealthFirst:
51662-1448
Recalls
- Oct 30, 2024 · Class II · Baxter Healthcare Corporation
Labeling: Missing Label
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.