Medicine
Naloxone and Pentazocine 0.5 mg/50 mg tablet
Naloxone and Pentazocine 0.5 mg/50 mg tablet is a generic prescription medicine for oral 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
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). Store Pentazocine and Naloxone Tablets…
Key facts
- Active ingredient (INN)
- Naloxone and Pentazocine
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaActavis Pharma3 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Store Pentazocine and Naloxone Tablets, USP securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIV
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 May 1997
- Identifiers
- RxCUI 312289DailyMed set ID a28450a0-ac93-4235-b9a6-58cdf24773cb, 017ef042-40aa-44c9-baa8-037f06356845, 41ebdaaf-3bbc-419f-b996-0341efc14623NDC 0591-0395, 43386-680, 63304-506Application ANDA074736, ANDA075735, ANDA075523
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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 63304-506-01 | Sun Pharmaceutical IndustriesIndia | 31 July 2018 |
| 100 tablet in 1 bottle, plastic | 0591-0395-01 | Actavis Pharma | 21 May 1997 |
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 16 December 1982 | 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
Clinical summary
Naloxone and Pentazocine is a fixed-dose combination of an opioid antagonist and a partial opioid agonist/antagonist. It is available as tablets for oral use. MedsAcross supplies Naloxone and Pentazocine 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 and PentazocineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- pentazocine and naloxone prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
Need Naloxone and Pentazocine 0.5 mg/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.