Naltrexone kit is a generic prescription medicine, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
The entire dose pack should be stored in the refrigerator (2°C to 8°C, 36°F to…
Key facts
- Active ingredient (INN)
- Naltrexone
- Brand
- Sold under the generic name
- Dosage form
- Kit
- Packs
- 1 kit
- Manufacturer
- Amneal Pharmaceuticals NY
- Origin register
- US FDA, United States
- Storage
- The entire dose pack should be stored in the refrigerator (2°C to 8°C, 36°F to 46°F). Unrefrigerated, naltrexone for extended-release injectable suspension can be stored at temperatures not exceeding 25°C (77°F) for no more than 7 days prior to administration. Do not expose the product to temperatures above 25°C (77°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N07BB04 Naltrexone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 May 2026
- Identifiers
- RxCUI 637213DailyMed set ID 6de5637f-d527-4228-af1a-3aae71155cb5NDC 69238-2794Application NDA021897
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 kit in 1 carton * 5 mL in 1 vial, glass * 4 mL in 1 vial, glass | 69238-2794-1 | Amneal Pharmaceuticals NY | 1 May 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 20 November 1984 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 Naltrexone kit.
Other strengths and forms of Naltrexone
Clinical summary
Naltrexone is an opioid antagonist indicated for the treatment of alcohol dependence in patients, among other approved uses. It is available as tablets and kits for oral use. MedsAcross supplies Naltrexone 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 NaltrexoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- VIVITROL prescribing information (Alkermes) · U.S. National Library of Medicine, DailyMed
Need Naltrexone kit 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.