Medicine
Motofen 0.025 mg/1 mg tablet
Motofen 0.025 mg/1 mg tablet is a prescription medicine containing Atropine and Difenoxin for oral use, marketed by Legacy Pharma, 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°-25°C (68°-77°F).
Key facts
- Active ingredient (INN)
- Atropine and Difenoxin
- Brand
- Motofen
- Strength
- 0.025 mg/1 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets
- Marketing authorisation holder
- Legacy Pharma
- Manufacturers
- Legacy PharmaSebela Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°-25°C (68°-77°F).
- 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
- 11 April 2017
- Identifiers
- RxCUI 1190738, 1190740DailyMed set ID 1fa11c67-5492-469c-9475-6bfa0e5e9ff8, 4cd3f029-a5e3-5812-e054-00144ff8d46cNDC 83107-011, 54766-200Application NDA017744
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 in 1 bottle | 83107-011-10 | Legacy Pharma | 1 January 2026 |
| 100 tablet in 1 bottle | 54766-200-10 | Sebela Pharmaceuticals | 11 April 2017 |
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 14 July 1978 | 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
Atropine and Difenoxin is a fixed-dose combination of an anticholinergic, an antidiarrheal and a cholinergic muscarinic antagonist indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea. MedsAcross supplies Atropine and Difenoxin 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 Atropine and DifenoxinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Motofen prescribing information (Legacy Pharma) · U.S. National Library of Medicine, DailyMed
Need Motofen 0.025 mg/1 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.