Medicine
Regadenoson 0.4 mg/5 mL injection
Regadenoson 0.4 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 13 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Regadenoson
- Brand
- Sold under the generic name
- Strength
- 0.4 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 5 mL, 1 syringe of 5 mL, 10 vials of 5 mL and 11 more
- Manufacturers
- Accord HealthcareIndiaEugiaIndiaGland PharmaIndiaApotexBaxter HealthcareHealthFirstHikma PharmaceuticalsHospiraIndies Pharma JamaicaInternational Medication Systems
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01EB21 Regadenoson
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 December 2019
- Identifiers
- DailyMed set ID 9e48b407-1ce3-461d-b48e-de183802de25, b183399d-b8dc-4924-90cd-a1c2247742f3, 288c76cc-ff3e-47ea-ae02-be566bd3e093 +10NDC 0641-6253, 85742-012, 76329-3321 +11Application ANDA215827, ANDA218054, ANDA214252 +8
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 5 mL in 1 syringe, glass | 16729-477-31 | Accord HealthcareIndia | 10 March 2023 |
| 1 syringe in 1 carton / 5 mL in 1 syringe | 55150-443-01 | EugiaIndia | 26 October 2022 |
| 10 vial in 1 carton / 5 mL in 1 vial | 68083-175-10 | Gland PharmaIndia | 12 July 2022 |
| 1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic | 60505-6116-0 | Apotex | 10 March 2023 |
| 1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic | 60505-6288-0 | Apotex | 3 April 2025 |
| 1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic | 36000-364-01 | Baxter Healthcare | 23 May 2023 |
| 1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic | 0641-6253-01 | Hikma Pharmaceuticals | 3 April 2023 |
| 10 carton in 1 package / 1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic | 0409-1401-01 | Hospira | 1 March 2023 |
| 1 syringe in 1 carton / 5 mL in 1 syringe | 83032-001-02 | Indies Pharma Jamaica | 22 August 2024 |
| 1 syringe in 1 carton / 5 mL in 1 syringe | 76329-3321-0 | International Medication Systems | 20 April 2023 |
| 1 syringe in 1 carton / 5 mL in 1 syringe | 85742-012-09 | Kanchan Healthcare | 22 August 2024 |
| 1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic | 71288-201-85 | Meitheal Pharmaceuticals | 11 April 2022 |
| 1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic | 51662-1448-1 | HealthFirst | 10 December 2019 |
| 1 syringe in 1 carton / 5 mL in 1 syringe | 10135-803-51 | Marlex Pharmaceuticals | 22 August 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Regadenoson 0.4 mg/5 mL injection.
Other strengths and forms of Regadenoson
Clinical summary
Regadenoson is a pharmacologic cardiac stress test agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. It is available as injection for intravenous use. MedsAcross supplies Regadenoson for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about RegadenosonFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- LEXISCAN prescribing information (Astellas Pharma) · U.S. National Library of Medicine, DailyMed
- Rapiscan: European public assessment report (EPAR) · European Medicines Agency
Need Regadenoson 0.4 mg/5 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.