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Medicine

Epinephrine 0.3 mg/0.3 mL injection

Epinephrine · Intramuscular
Available on requestPrescription onlyUS FDAGeneric name

Epinephrine 0.3 mg/0.3 mL injection is a generic prescription medicine for intramuscular use, made by 5 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°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…

Key facts

Active ingredient (INN)
Epinephrine
Brand
Sold under the generic name
Strength
0.3 mg/0.3 mL
Dosage form
Injection
Route
Intramuscular
Packs
1 container of 0.3 mL, 2 containers of 0.3 mL, 1 syringe of 0.3 mL and 2 more
Manufacturers
HealthFirstMedical Purchasing SolutionsSina HealthSportpharmViatris Specialty
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). • Do not refrigerate. • Before using, check to make sure the solution in the auto-injector is clear and colorless.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
A01AD01 Epinephrine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
15 December 2016
Identifiers
RxCUI 727316, 1870207DailyMed set ID 778ac6ae-6bcb-47a4-bcb3-8dd0da9f8836, 6bce7d5c-bb6b-1f36-e053-2a91aa0a68ab, 75e96faa-545b-52d6-e053-2991aa0a8fb8 +2NDC 49502-102, 71872-7135, 51662-1224 +2Application NDA019430

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
1 container in 1 package / 1 syringe, glass in 1 container / .3 mL in 1 syringe, glass70385-2019-1Sina Health15 December 2016
2 container in 1 carton / 1 syringe, glass in 1 container / .3 mL in 1 syringe, glass49502-102-02Viatris Specialty15 December 2016
1 syringe, glass in 1 container / .3 mL in 1 syringe, glass51662-1224-1HealthFirst15 September 2018
1 container in 1 bag / 1 syringe, glass in 1 container / .3 mL in 1 syringe, glass71872-7135-1Medical Purchasing Solutions11 April 2018
2 container in 1 carton / 1 syringe, glass in 1 container / .3 mL in 1 syringe, glass85766-304-02Sportpharm13 October 2026
1 case in 1 carton / 1 syringe, glass in 1 case / .3 mL in 1 syringe, glass0115-1694-30—1 April 2010
2 case in 1 carton / 1 syringe, glass in 1 case / .3 mL in 1 syringe, glass0115-1694-49—1 April 2010
1 case in 1 package / 1 syringe, glass in 1 case / .3 mL in 1 syringe, glass70385-2022-1—1 April 2010
2 case in 1 carton / 1 syringe, glass in 1 case / .3 mL in 1 syringe, glass76420-467-02—4 September 2025
1 case in 1 carton / 1 syringe, glass in 1 case / .3 mL in 1 syringe, glass76420-834-01—2 August 2024
2 case in 1 carton / 1 syringe, glass in 1 case / .3 mL in 1 syringe, glass76420-834-02—2 August 2024
2 case in 1 carton / 1 syringe in 1 case / .3 mL in 1 syringe80425-0264-1—16 February 2023
1 syringe, glass in 1 case / .3 mL in 1 syringe, glass51662-1223-1—15 September 2018
2 case in 1 carton / 1 syringe, glass in 1 case / .3 mL in 1 syringe, glass70518-2048-0—29 April 2019
1 case in 1 carton / 1 syringe, glass in 1 case / .3 mL in 1 syringe, glass85766-061-01—3 February 2026
2 case in 1 carton / 1 syringe, glass in 1 case / .3 mL in 1 syringe, glass85766-061-02—4 September 2025
2 container in 1 carton / 1 syringe in 1 container / .3 mL in 1 syringe0093-5986-27—27 November 2018
2 syringe in 1 package / .3 mL in 1 syringe76420-188-02—28 January 2021
2 container in 1 carton / 1 syringe in 1 container / .3 mL in 1 syringe67296-1946-2—27 November 2018
2 container in 1 carton / 1 syringe in 1 container / .3 mL in 1 syringe70518-2283-0—26 August 2019
2 container in 1 carton / 1 syringe in 1 container / .3 mL in 1 syringe85766-091-02—10 October 2025
2 case in 1 carton / 1 mL in 1 case50090-3155-0—5 October 2017

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 8 June 1951Drugs@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 Epinephrine 0.3 mg/0.3 mL injection.

Compare all 4

Other strengths and forms of Epinephrine

Clinical summary

Epinephrine is a catecholamine. It is available as injection, nasal spray and kits for intramuscular, subcutaneous and intravenous use. MedsAcross supplies Epinephrine 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 Epinephrine

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

Data sources

Need Epinephrine 0.3 mg/0.3 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.