Medicine
Kloxxado 8 mg/0.1 mL nasal spray
Kloxxado 8 mg/0.1 mL nasal spray is a prescription medicine containing Naloxone for nasal use, marketed by Hikma Specialty, 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. KLOXXADO freezes at temperatures below -15°C (5°F). Store at…
Key facts
- Active ingredient (INN)
- Naloxone
- Brand
- Kloxxado
- Strength
- 8 mg/0.1 mL
- Dosage form
- Nasal spray
- Route
- Nasal
- Packs
- .1 mL
- Marketing authorisation holder
- Hikma Specialty
- Manufacturer
- Hikma Specialty
- Origin register
- US FDA, United States
- Storage
- Do not freeze. KLOXXADO freezes at temperatures below -15°C (5°F). Store at 20ºC to 25ºC (68ºF to 77ºF), with excursions permitted to 40°C (104°F) and to 5°C (41°F). Do not store at or above 40°C (104°F). However, KLOXXADO may be thawed by allowing it to sit at room temperature for 15 minutes, and it may still be used if it has been thawed after being previously frozen.
- 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
- 3 August 2021
- Identifiers
- RxCUI 2540703, 2540709DailyMed set ID ebf0f833-c1c0-487c-8f29-01fa8c61b6cbNDC 59467-679Application NDA212045
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| .1 mL in 1 vial, single-dose | 59467-679-01 | Hikma Specialty | 3 August 2021 |
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.
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 NaloxoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Narcan prescribing information (Emergent Devices) · U.S. National Library of Medicine, DailyMed
- Nyxoid: European public assessment report (EPAR) · European Medicines Agency
Need Kloxxado 8 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.