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MedsAcross

Medicine

Naloxone 4 mg/0.1 mL nasal spray

Naloxone · Nasal
Available on requestPrescription onlyUS FDAGeneric name

Naloxone 4 mg/0.1 mL nasal spray is a generic prescription medicine for nasal use, made by 3 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

Do not freeze. Store at room temperature 59°F to 77°F (15°C to 25°C)…

Key facts

Active ingredient (INN)
Naloxone
Brand
Sold under the generic name
Strength
4 mg/0.1 mL
Dosage form
Nasal spray
Route
Nasal
Packs
.1 mL, 2 vials and 3 more
Manufacturers
HealthFirstA-S Medication SolutionsProficient Rx
Origin register
US FDA, United States
Storage
Do not freeze. Store at room temperature 59°F to 77°F (15°C to 25°C). Excursions permitted up to 104°F (40°C). Store NARCAN Nasal Spray in the blister and cartons provided. Protect from light.
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
15 October 2018
Identifiers
RxCUI 1725059DailyMed set ID 784a0e98-c2d6-f845-e053-2991aa0ac4b4, f8fcda15-8ba6-e66a-e053-6294a90a385c, 0b3b5214-6f91-4bba-82d6-d57b16845df5 +1NDC 51662-1240, 51662-1620, 50090-6710 +1Application NDA208411, ANDA211951

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 mL in 1 vial, single-dose51662-1240-1HealthFirst15 October 2018
2 vial, single-dose in 1 package / .1 mL in 1 vial, single-dose51662-1240-2HealthFirst15 October 2018
.1 mL in 1 vial, single-dose51662-1620-1HealthFirst10 April 2023
2 vial, single-dose in 1 carton / .1 mL in 1 vial, single-dose51662-1620-2HealthFirst10 April 2023
2 vial, single-dose in 1 carton / .1 mL in 1 vial, single-dose50090-6710-0A-S Medication Solutions28 September 2023
2 vial, single-dose in 1 carton / .1 mL in 1 vial, single-dose71205-707-02Proficient Rx20 October 2022

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 4 mg/0.1 mL nasal spray.

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 4 mg/0.1 mL nasal spray 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.