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Medicine

Epinephrine 1 mg/1 mL injection

Epinephrine · Intramuscular, intraocular, intravenous, subcutaneous
Available on requestPrescription onlyUS FDAGeneric name

Epinephrine 1 mg/1 mL injection is a generic prescription medicine for intramuscular, intraocular, intravenous, subcutaneous use, made by 7 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 room temperature, between 20° to 25°C (68° to 77°F). Protect from…

Key facts

Active ingredient (INN)
Epinephrine
Brand
Sold under the generic name
Strength
1 mg/1 mL
Dosage form
Injection
Route
Intramuscular, intraocular, intravenous, subcutaneous
Packs
10 ampules of 1 mL, 25 vials of 1 mL, 1 mL and 4 more
Manufacturers
Gland PharmaIndiaGlenmark PharmaceuticalsIndiaA-S Medication SolutionsBPI LabsFresenius KabiProPharma DistributionRemedyrepack
Origin register
US FDA, United States
Storage
Store at room temperature, between 20° to 25°C (68° to 77°F). Protect from alkalis and oxidizing agents.
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
8 August 2014
Identifiers
RxCUI 1660014DailyMed set ID 384445ac-0696-e367-e063-6394a90a019f, a6afb9e8-1db9-480c-8d31-58c5c870ca49, 01fd19cd-190c-4989-b733-60ba95941297 +4NDC 84549-103, 63323-696, 68462-933 +4Application NDA205029, ANDA213708, ANDA218144

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
10 ampule in 1 box / 1 mL in 1 ampule68083-591-10Gland PharmaIndia3 June 2025
10 ampule in 1 box / 1 mL in 1 ampule68462-933-10Glenmark PharmaceuticalsIndia3 June 2025
10 ampule in 1 box / 1 mL in 1 ampule54288-103-10BPI Labs8 August 2014
25 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose63323-696-25Fresenius Kabi21 November 2024
1 mL in 1 ampule50090-3039-1A-S Medication Solutions6 June 2017
1 mL in 1 ampule84549-103-10ProPharma Distribution27 August 2025
25 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose70518-4274-0Remedyrepack3 February 2025
10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose68083-699-10—22 September 2026
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose68083-699-25—22 September 2026
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose68462-762-25—22 September 2026
1 vial, multi-dose in 1 carton / 1 mL in 1 vial, multi-dose70121-1660-2—14 October 2025
25 vial, glass in 1 carton / 1 mL in 1 vial, glass80830-1659-2—8 December 2025
1 vial in 1 carton / 1 mL in 1 vial0517-3030-01—9 October 2024
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose43066-803-25—30 March 2026
10 vial in 1 carton / 1 mL in 1 vial54288-119-10—7 March 2024
25 vial in 1 carton / 1 mL in 1 vial54288-119-25—7 March 2024
25 ampule in 1 carton / 1 mL in 1 ampule0143-9476-25—8 June 2026
25 pouch in 1 box / 1 vial in 1 pouch / 1 mL in 1 vial51662-1706-3—16 March 2022
25 pouch in 1 case / 1 ampule in 1 pouch / 1 mL in 1 ampule51662-1708-3—8 June 2026
1 vial in 1 bag / 1 mL in 1 vial71872-7360-1—2 October 2024
25 vial in 1 carton / 1 mL in 1 vial70518-4156-0—12 August 2024
10 syringe, glass in 1 carton / 1 mL in 1 syringe, glass54288-117-10—24 May 2023
1 ampule in 1 bag / 1 mL in 1 ampule0404-9857-01—10 January 2022
1 ampule in 1 bag / 1 mL in 1 ampule71872-7117-1—5 March 2018
10 ampule in 1 box / 1 mL in 1 ampule0517-1171-10—31 January 2023
1 mL in 1 vial, single-dose51662-1290-1—21 September 2018
25 pouch in 1 case / 1 mL in 1 pouch51662-1290-3—29 April 2020
2 container in 1 carton / 1 mL in 1 container50090-4543-0—20 September 2019

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 1 mg/1 mL injection.

Compare all 6

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 1 mg/1 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.