Medicine
Atropine and Diphenoxylate 0.025 mg/2.5 mg per 5 mL oral solution
Atropine and Diphenoxylate 0.025 mg/2.5 mg per 5 mL oral solution is a generic prescription medicine for oral use, 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)
- Atropine and Diphenoxylate
- Brand
- Sold under the generic name
- Strength
- 0.025 mg/2.5 mg per 5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle
- Manufacturer
- Hikma 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 CV
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 May 1982
- Identifiers
- RxCUI 1190568DailyMed set ID 88ed4ccf-9e35-4142-a5eb-d2b5edd36956NDC 0054-3194Application ANDA087708
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 bottle in 1 carton / 60 mL in 1 bottle | 0054-3194-46 | Hikma Pharmaceuticals | 3 May 1982 |
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 15 September 1960 | 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 Atropine and Diphenoxylate
Clinical summary
Atropine and Diphenoxylate is a fixed-dose combination of an anticholinergic, an antidiarrheal and a cholinergic muscarinic antagonist indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older. MedsAcross supplies Atropine and Diphenoxylate 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 DiphenoxylateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Diphenoxylate Hydrochloride and Atropine Sulfate prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Atropine and Diphenoxylate 0.025 mg/2.5 mg per 5 mL oral solution 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.