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Medicine

Regadenoson 0.4 mg/5 mL injection

Regadenoson · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

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

Available on request

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.

PackCodeLabelerMarketed since
5 mL in 1 syringe, glass16729-477-31Accord HealthcareIndia10 March 2023
1 syringe in 1 carton / 5 mL in 1 syringe55150-443-01EugiaIndia26 October 2022
10 vial in 1 carton / 5 mL in 1 vial68083-175-10Gland PharmaIndia12 July 2022
1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic60505-6116-0Apotex10 March 2023
1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic60505-6288-0Apotex3 April 2025
1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic36000-364-01Baxter Healthcare23 May 2023
1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic0641-6253-01Hikma Pharmaceuticals3 April 2023
10 carton in 1 package / 1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic0409-1401-01Hospira1 March 2023
1 syringe in 1 carton / 5 mL in 1 syringe83032-001-02Indies Pharma Jamaica22 August 2024
1 syringe in 1 carton / 5 mL in 1 syringe76329-3321-0International Medication Systems20 April 2023
1 syringe in 1 carton / 5 mL in 1 syringe85742-012-09Kanchan Healthcare22 August 2024
1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic71288-201-85Meitheal Pharmaceuticals11 April 2022
1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic51662-1448-1HealthFirst10 December 2019
1 syringe in 1 carton / 5 mL in 1 syringe10135-803-51Marlex Pharmaceuticals22 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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 10 April 2008Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

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.

Compare 1

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 Regadenoson

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

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.