Medicine
Naltrexone 50 mg tablet
Naltrexone 50 mg tablet is a generic prescription medicine for oral use, made by 21 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Naltrexone
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 1000 tablets and 91 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaAccord HealthcareIndiaAvet PharmaceuticalsIndiaBryant Ranch PrepackChartwell RXElite LaboratoriesSpecGxTAGI Pharma21 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light.
- Cold chain
- Not required on record
- 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
- 22 March 2002
- Identifiers
- RxCUI 1483744DailyMed set ID d7ba0156-6222-4619-a043-b5a1342d5375, 68cb0399-ca56-4310-8531-6b5552b71b25, f3305f0b-fb9e-4009-b28f-47fe9b1b618b +37NDC 71335-2419, 71335-2743, 82804-199 +37Application ANDA075274, ANDA090356, ANDA076264 +2
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
A sample of 40 packs from 21 labelers. The register lists 94 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 16729-081-01 | Accord HealthcareIndia | 18 January 2012 |
| 30 tablet, film coated in 1 bottle | 16729-081-10 | Accord HealthcareIndia | 18 January 2012 |
| 100 tablet, film coated in 1 bottle | 23155-886-01 | Avet PharmaceuticalsIndia | 6 October 2023 |
| 30 tablet, film coated in 1 bottle | 23155-886-03 | Avet PharmaceuticalsIndia | 6 October 2023 |
| 100 tablet, film coated in 1 bottle | 47335-326-08 | Sun Pharmaceutical IndustriesIndia | 29 February 2012 |
| 1000 tablet, film coated in 1 bottle | 47335-326-18 | Sun Pharmaceutical IndustriesIndia | 29 February 2012 |
| 30 tablet, film coated in 1 bottle | 47335-326-83 | Sun Pharmaceutical IndustriesIndia | 29 February 2012 |
| 100 tablet, film coated in 1 bottle | 47335-326-88 | Sun Pharmaceutical IndustriesIndia | 29 February 2012 |
| 30 tablet, film coated in 1 bottle | 62135-242-30 | Chartwell RX | 5 January 2022 |
| 60 tablet, film coated in 1 bottle | 62135-242-60 | Chartwell RX | 11 June 2024 |
| 90 tablet, film coated in 1 bottle | 62135-242-90 | Chartwell RX | 5 January 2022 |
| 100 tablet, film coated in 1 bottle | 64850-300-01 | Elite Laboratories | 15 August 2025 |
| 30 tablet, film coated in 1 bottle | 64850-300-30 | Elite Laboratories | 15 August 2025 |
| 100 tablet, film coated in 1 bottle | 0406-1170-01 | SpecGx | 22 March 2002 |
| 30 tablet, film coated in 1 bottle | 0406-1170-03 | SpecGx | 22 March 2002 |
| 30 tablet, film coated in 1 bottle | 51224-206-30 | TAGI Pharma | 23 September 2013 |
| 100 tablet, film coated in 1 bottle | 51224-206-50 | TAGI Pharma | 23 September 2013 |
| 100 tablet, film coated in 1 bottle | 63629-1047-1 | Bryant Ranch Prepack | 23 September 2013 |
| 30 tablet, film coated in 1 bottle | 71335-0014-1 | Bryant Ranch Prepack | 14 May 2026 |
| 90 tablet, film coated in 1 bottle | 71335-0014-2 | Bryant Ranch Prepack | 14 May 2026 |
| 60 tablet, film coated in 1 bottle | 71335-0014-3 | Bryant Ranch Prepack | 14 May 2026 |
| 45 tablet, film coated in 1 bottle | 71335-0014-4 | Bryant Ranch Prepack | 14 May 2026 |
| 120 tablet, film coated in 1 bottle | 71335-0014-5 | Bryant Ranch Prepack | 14 May 2026 |
| 15 tablet, film coated in 1 bottle | 71335-0014-6 | Bryant Ranch Prepack | 14 May 2026 |
| 100 tablet, film coated in 1 bottle | 71335-0014-7 | Bryant Ranch Prepack | 14 May 2026 |
| 30 tablet, film coated in 1 bottle | 71335-1480-1 | Bryant Ranch Prepack | 16 January 2020 |
| 90 tablet, film coated in 1 bottle | 71335-1480-2 | Bryant Ranch Prepack | 22 January 2020 |
| 60 tablet, film coated in 1 bottle | 71335-1480-3 | Bryant Ranch Prepack | 30 May 2024 |
| 45 tablet, film coated in 1 bottle | 71335-1480-4 | Bryant Ranch Prepack | 30 May 2024 |
| 120 tablet, film coated in 1 bottle | 71335-1480-5 | Bryant Ranch Prepack | 30 May 2024 |
| 15 tablet, film coated in 1 bottle | 71335-1480-6 | Bryant Ranch Prepack | 10 September 2020 |
| 30 tablet, film coated in 1 bottle | 71335-2062-1 | Bryant Ranch Prepack | 21 March 2022 |
| 90 tablet, film coated in 1 bottle | 71335-2062-2 | Bryant Ranch Prepack | 21 March 2022 |
| 60 tablet, film coated in 1 bottle | 71335-2062-3 | Bryant Ranch Prepack | 21 March 2022 |
| 45 tablet, film coated in 1 bottle | 71335-2062-4 | Bryant Ranch Prepack | 21 March 2022 |
| 120 tablet, film coated in 1 bottle | 71335-2062-5 | Bryant Ranch Prepack | 21 March 2022 |
| 15 tablet, film coated in 1 bottle | 71335-2062-6 | Bryant Ranch Prepack | 21 March 2022 |
| 100 tablet, film coated in 1 bottle | 71335-2062-7 | Bryant Ranch Prepack | 21 March 2022 |
| 30 tablet, film coated in 1 bottle | 71335-2419-1 | Bryant Ranch Prepack | 12 November 2024 |
| 90 tablet, film coated in 1 bottle | 71335-2419-2 | Bryant Ranch Prepack | 12 November 2024 |
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
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 50 mg tablet 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.