Quick answers
- What is Regadenoson (regadenoson anhydrous) used for?
- The FDA-approved label (Regadenoson, Hospira, Inc., December 8, 2025) says: “Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Regadenoson (regadenoson anhydrous) have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Regadenoson (regadenoson anhydrous)?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Regadenoson (regadenoson anhydrous) been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Regadenoson (regadenoson anhydrous)?
- 4 companies list prescription products of Regadenoson (regadenoson anhydrous) in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., International Medication Systems, Limited and Dr. Reddy's Laboratories Inc..
What Regadenoson (regadenoson anhydrous) is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
— FDA label: Regadenoson, Hospira, Inc., effective December 8, 2025. Read the full label on DailyMed →
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 4 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hikma Pharmaceuticals USA Inc.1 product
- International Medication Systems, Limited1 product
- Dr. Reddy's Laboratories Inc.1 product
- Hospira, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (4)
- ANDA213210DR Reddys · April 11, 2022
- ANDA214252Ims Ltd · May 23, 2022
- ANDA214349Hospira · August 31, 2022
- ANDA215827Hikma · February 2, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | 0e3f080d-b1fb-47ed-8cd3-90a4206fa704 |
|---|---|
| FDA labels (SPL) | 4 |
| FDA applications | 4 ANDA |
| Active ingredients (FDA) | REGADENOSON ANHYDROUS |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Regadenoson, Hospira, Inc., effective December 8, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →