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Medicine

Naloxone 0.4 mg/1 mL injection

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

Naloxone 0.4 mg/1 mL injection is a generic prescription medicine for intramuscular, intravenous, subcutaneous use, made by 18 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). Protect from light. Store in carton…

Key facts

Active ingredient (INN)
Naloxone
Brand
Sold under the generic name
Strength
0.4 mg/1 mL
Dosage form
Injection
Route
Intramuscular, intravenous, subcutaneous
Packs
10 vials of 1 mL, 25 vials of 1 mL, 1 vial of 1 mL and 34 more
Manufacturers
Lifestar PharmaIndiaEugiaIndiaHealthFirstMedical Purchasing SolutionsHikma PharmaceuticalsA-S Medication SolutionsHealth FirstHenry ScheinHospiraNorthStar RxLLC
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F 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
24 September 1986
Identifiers
RxCUI 1659929, 1191222, 1191250 +2DailyMed set ID d4c44b74-4e36-4b63-80eb-64ce99ccb39f, 8cc25cf1-008c-4808-baec-49f35a887fae, 2879294f-9af9-459e-e063-6394a90a0820 +26NDC 72603-590, 0641-6132, 70385-2033 +26Application ANDA218404, ANDA070299, ANDA207633 +7

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, single-dose in 1 carton / 1 mL in 1 vial, single-dose70756-658-10Lifestar PharmaIndia29 February 2024
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose70756-658-25Lifestar PharmaIndia29 February 2024
1 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose70756-658-82Lifestar PharmaIndia29 February 2024
10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose70756-850-10Lifestar PharmaIndia19 February 2026
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose70756-850-25Lifestar PharmaIndia19 February 2026
1 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose70756-850-82Lifestar PharmaIndia19 February 2026
10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose55150-327-10EugiaIndia15 October 2019
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose55150-327-25EugiaIndia15 October 2019
25 vial in 1 carton / 1 mL in 1 vial0641-6132-25Hikma Pharmaceuticals24 September 1986
10 syringe in 1 carton / 1 mL in 1 syringe0641-6193-10Hikma Pharmaceuticals31 August 2025
25 vial in 1 carton / 1 mL in 1 vial0641-6260-25Hikma Pharmaceuticals1 March 2022
10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose0409-1215-01Hospira12 July 2005
10 cartridge in 1 box / 1 mL in 1 cartridge0409-1782-69Hospira23 September 2005
10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose36000-308-10Baxter Healthcare29 January 2021
24 syringe in 1 carton / 1 mL in 1 syringe76045-114-10Fresenius Kabi2 April 2024
1 mL in 1 vial51662-1242-1Health First18 August 2018
50 pouch in 1 case / 1 mL in 1 pouch51662-1242-3Health First15 June 2020
10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose67457-292-02Mylan Institutional6 March 2014
1 vial in 1 package / 1 mL in 1 vial70385-2033-1Sina Health8 August 2017
10 vial in 1 carton / 1 mL in 1 vial70069-071-10Somerset Therapeutics8 August 2017
1 vial in 1 bag / 1 mL in 1 vial71872-7009-1Medical Purchasing Solutions6 May 2019
1 vial in 1 bag / 1 mL in 1 vial71872-7198-1Medical Purchasing Solutions29 January 2020
1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose71872-7219-1Medical Purchasing Solutions11 September 2020
1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose71872-7297-1Medical Purchasing Solutions16 November 2022
1 mL in 1 cartridge51662-1238-1HealthFirst3 September 2018
1 mL in 1 vial, single-dose51662-1544-1HealthFirst8 August 2021
10 pouch in 1 case / 1 vial, single-dose in 1 pouch / 1 mL in 1 vial, single-dose51662-1544-3HealthFirst22 April 2022
25 vial in 1 carton / 1 mL in 1 vial51662-1671-3HealthFirst24 September 1986
10 vial in 1 carton / 1 mL in 1 vial50090-5427-0A-S Medication Solutions8 January 2021
10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose50090-6491-0A-S Medication Solutions19 May 2023
1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose0404-9773-01Henry Schein28 October 2025
1 box in 1 bag / 1 cartridge in 1 box / 1 mL in 1 cartridge0404-9920-01Henry Schein13 January 2022
25 vial in 1 carton / 1 mL in 1 vial72572-450-25Civica11 November 2019
10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose72603-590-10NorthStar RxLLC1 July 2024
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose72603-590-25NorthStar RxLLC1 July 2024
1 mL in 1 vial84549-071-10ProPharma Distribution27 August 2025
10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose70518-4785-0Remedyrepack28 October 2026

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 0.4 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.