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MedsAcross

Medicine

Naloxone 4 mg/10 mL injection

Naloxone · Intramuscular, intravenous, subcutaneous
Available on requestPrescription onlyUS FDAGeneric name

Naloxone 4 mg/10 mL injection is a generic prescription medicine for intramuscular, intravenous, subcutaneous use, made by 8 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). Protect from light. Store in carton until…

Key facts

Active ingredient (INN)
Naloxone
Brand
Sold under the generic name
Strength
4 mg/10 mL
Dosage form
Injection
Route
Intramuscular, intravenous, subcutaneous
Packs
10 vials of 10 mL, 25 vials of 10 mL, 1 vial of 10 mL and 9 more
Manufacturers
EugiaIndiaHealthFirstMedical Purchasing SolutionsBaxter HealthcareHospiraMylan InstitutionalProPharma DistributionSomerset Therapeutics
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F). Protect from light. Store in carton until contents have been used.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
A06AH04 Naloxone
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
2 September 2005
Identifiers
RxCUI 1191222, 1659929DailyMed set ID ada6856c-5293-fc2f-e053-2995a90a8ec6, 28f3e3bc-b1be-9f06-e063-6394a90a1936, 94ff1857-06da-7986-e053-2a95a90afb18 +8NDC 71872-7215, 71872-7326, 51662-1385 +8Application ANDA212456, ANDA207634, ANDA070257 +2

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 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose55150-328-10EugiaIndia4 November 2019
25 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose55150-328-25EugiaIndia4 November 2019
1 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose36000-310-02Baxter Healthcare7 November 2022
25 carton in 1 case / 1 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose0409-1219-01Hospira2 September 2005
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose67457-299-10Mylan Institutional14 September 2016
10 carton in 1 box / 1 vial, glass in 1 carton / 10 mL in 1 vial, glass70069-072-10Somerset Therapeutics26 July 2017
1 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose51662-1385-1HealthFirst15 October 2019
1 vial, glass in 1 carton / 10 mL in 1 vial, glass51662-1426-1HealthFirst10 January 2020
10 mL in 1 vial, glass51662-1673-1HealthFirst26 July 2017
1 vial, multi-dose in 1 bag / 10 mL in 1 vial, multi-dose71872-7215-1Medical Purchasing Solutions15 June 2020
1 carton in 1 bag / 1 vial, glass in 1 carton / 10 mL in 1 vial, glass71872-7326-1Medical Purchasing Solutions19 June 2024
10 mL in 1 vial, glass84549-072-10ProPharma Distribution19 September 2025

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 13 April 1971Drugs@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

Other strengths and forms of Naloxone

Clinical summary

Naloxone is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. MedsAcross supplies Naloxone 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 Naloxone

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

Data sources

Need Naloxone 4 mg/10 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.