Medicine
Tuxarin 8 mg/54.3 mg extended-release tablet
Tuxarin 8 mg/54.3 mg extended-release tablet is a prescription medicine containing Chlorpheniramine and Codeine for oral use, marketed by Mainpointe Pharmaceuticals, 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).
Key facts
- Active ingredient (INN)
- Chlorpheniramine and Codeine
- Brand
- Tuxarin
- Strength
- 8 mg/54.3 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets
- Marketing authorisation holder
- Mainpointe Pharmaceuticals
- Manufacturer
- Mainpointe Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20 to 25°C (68 to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIII
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 October 2018
- Identifiers
- RxCUI 1664543, 2099286DailyMed set ID a7cfab67-6087-4ab4-b7cd-4f9295413180NDC 71269-040Application NDA206323
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 |
|---|---|---|---|
| 100 tablet, extended release in 1 bottle, plastic | 71269-040-10 | Mainpointe Pharmaceuticals | 15 October 2018 |
| 30 tablet, extended release in 1 bottle, plastic | 71269-040-30 | Mainpointe Pharmaceuticals | 15 October 2018 |
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 22 June 2015 | 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
Chlorpheniramine and Codeine is a fixed-dose combination of a histamine-1 receptor antagonist and an opioid agonist. It is available as extended-release tablets for oral use. MedsAcross supplies Chlorpheniramine and Codeine 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 Chlorpheniramine and CodeineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Tuxarin prescribing information (Mainpointe Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Tuxarin 8 mg/54.3 mg extended-release 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.