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MedsAcross

Medicine

Naloxone 2 mg/2 mL injection

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

Naloxone 2 mg/2 mL injection is a generic prescription medicine for intramuscular, intravenous, subcutaneous use, made by 9 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
2 mg/2 mL
Dosage form
Injection
Route
Intramuscular, intravenous, subcutaneous
Packs
10 syringes of 2 mL, 1 syringe of 2 mL, 10 cartons of 2 mL and 12 more
Manufacturers
Dr. Reddy's LaboratoriesIndiaEugiaIndiaHealthFirstBaxter HealthcareFresenius KabiHikma PharmaceuticalsMedical Purchasing SolutionsMylan InstitutionalPar Health
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 time of use.
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
18 March 2020
Identifiers
RxCUI 1191250, 2679504DailyMed set ID 3ae08e26-223b-4971-b2f1-f1e183a3f930, 201fdedf-1736-4e52-9d7d-de14292547fd, e65e03c1-9a66-b30b-e053-2995a90aeb73 +8NDC 42023-224, 76045-112, 51662-1586 +8Application ANDA215964, ANDA213573, ANDA213279 +4

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 syringe in 1 box / 2 mL in 1 syringe43598-750-10Dr. Reddy's LaboratoriesIndia10 September 2024
1 syringe in 1 box / 2 mL in 1 syringe43598-750-11Dr. Reddy's LaboratoriesIndia18 March 2020
1 syringe in 1 box / 2 mL in 1 syringe55150-345-01EugiaIndia14 January 2021
10 syringe in 1 box / 2 mL in 1 syringe55150-345-10EugiaIndia14 January 2021
10 carton in 1 carton / 1 syringe, glass in 1 carton / 2 mL in 1 syringe, glass43066-142-10Baxter Healthcare3 June 2025
24 syringe in 1 case / 2 mL in 1 syringe76045-112-20Fresenius Kabi2 April 2024
10 syringe in 1 carton / 2 mL in 1 syringe0641-6205-10Hikma Pharmaceuticals10 June 2022
1 syringe, glass in 1 carton / 2 mL in 1 syringe, glass67457-992-02Mylan Institutional2 December 2022
1 syringe, glass in 1 carton / 2 mL in 1 syringe, glass42023-224-01Par Health5 November 2024
1 syringe in 1 box / 2 mL in 1 syringe51662-1529-1HealthFirst15 July 2021
10 pouch in 1 box / 1 syringe in 1 pouch / 2 mL in 1 syringe51662-1529-3HealthFirst11 May 2022
1 syringe in 1 box / 2 mL in 1 syringe51662-1586-1HealthFirst16 August 2022
10 pouch in 1 case / 1 box in 1 pouch / 1 syringe in 1 box / 2 mL in 1 syringe51662-1586-3HealthFirst16 August 2022
10 pouch in 1 case / 1 box in 1 pouch / 1 syringe in 1 box / 2 mL in 1 syringe51662-1690-3HealthFirst18 March 2020
1 syringe in 1 bag / 2 mL in 1 syringe71872-7299-1Medical Purchasing Solutions25 January 2023
10 syringe in 1 box / 2 mL in 1 syringe76329-1469-1—1 April 1998
10 syringe in 1 box / 2 mL in 1 syringe76329-3369-1—1 June 2001
10 syringe in 1 box / 2 mL in 1 syringe76329-3469-1—28 July 2016
1 syringe in 1 bag / 2 mL in 1 syringe71872-7177-1—9 September 2019
1 syringe in 1 bag / 2 mL in 1 syringe71872-7294-1—22 July 2022
1 syringe, plastic in 1 box / 2 mL in 1 syringe, plastic51662-1239-1—3 September 2018
1 syringe in 1 bag / 2 mL in 1 syringe0404-9922-02—13 January 2022
10 syringe in 1 box / 2 mL in 1 syringe70518-2725-0—5 May 2020

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

Alternatives

Other makers and brands of Naloxone 2 mg/2 mL injection.

Compare 1

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 2 mg/2 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.