Medicine
Atropine and Diphenoxylate 0.025 mg/2.5 mg tablet
Atropine and Diphenoxylate 0.025 mg/2.5 mg tablet is a generic prescription medicine for oral use, made by 18 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), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Atropine and Diphenoxylate
- Brand
- Sold under the generic name
- Strength
- 0.025 mg/2.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 120 tablets and 80 more
- Manufacturers
- Unichem LaboratoriesIndiaAphena Pharma Solutions - TennesseeWinder LaboratoriesLeading PharmaANI PharmaceuticalsSpecGxA-S Medication SolutionsChartwell RXMylan Pharmaceuticals18 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°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
- 7 August 2012
- Identifiers
- RxCUI 1190572DailyMed set ID c832ef16-a06e-4e47-9df3-ab33bdfa6e56, f4c35a82-5927-5bc2-e053-2a95a90aea4d, 1c188bc9-7c21-4717-94a0-cdfb581fb776 +23NDC 63187-939, 67296-1485, 69315-910 +23Application ANDA086727, ANDA213413, NDA012462 +4
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 18 labelers. The register lists 83 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 76385-107-01 | Unichem LaboratoriesIndia | 15 May 2019 |
| 1000 tablet in 1 bottle | 76385-107-10 | Unichem LaboratoriesIndia | 15 May 2019 |
| 100 tablet in 1 bottle | 62559-490-01 | ANI Pharmaceuticals | 7 July 2017 |
| 1000 tablet in 1 bottle | 62559-490-10 | ANI Pharmaceuticals | 7 July 2017 |
| 120 tablet in 1 bottle | 62135-618-12 | Chartwell RX | 8 June 2022 |
| 100 tablet in 1 bottle | 69315-910-01 | Leading Pharma | 15 March 2020 |
| 90 tablet in 1 bottle | 69315-910-09 | Leading Pharma | 15 March 2020 |
| 1000 tablet in 1 bottle | 69315-910-10 | Leading Pharma | 15 March 2020 |
| 100 tablet in 1 bottle | 59762-1061-1 | Mylan Pharmaceuticals | 7 August 2012 |
| 100 tablet in 1 bottle | 0406-1236-01 | SpecGx | 30 October 2020 |
| 1000 tablet in 1 bottle | 0406-1236-10 | SpecGx | 30 October 2020 |
| 1000 tablet in 1 bottle, plastic | 75826-107-00 | Winder Laboratories | 1 September 2022 |
| 100 tablet in 1 bottle, plastic | 75826-107-03 | Winder Laboratories | 1 September 2022 |
| 10 tablet in 1 bottle, plastic | 75826-107-11 | Winder Laboratories | 1 September 2022 |
| 30 tablet in 1 bottle, plastic | 75826-107-33 | Winder Laboratories | 1 September 2022 |
| 90 tablet in 1 bottle, plastic | 75826-107-90 | Winder Laboratories | 1 September 2022 |
| 30 tablet in 1 bottle | 43353-083-30 | Aphena Pharma Solutions - Tennessee | 13 July 2015 |
| 60 tablet in 1 bottle | 43353-083-53 | Aphena Pharma Solutions - Tennessee | 14 July 2015 |
| 90 tablet in 1 bottle | 43353-083-60 | Aphena Pharma Solutions - Tennessee | 13 July 2015 |
| 120 tablet in 1 bottle | 43353-083-70 | Aphena Pharma Solutions - Tennessee | 13 July 2015 |
| 180 tablet in 1 bottle | 43353-083-80 | Aphena Pharma Solutions - Tennessee | 15 August 2015 |
| 240 tablet in 1 bottle | 43353-083-90 | Aphena Pharma Solutions - Tennessee | 27 July 2015 |
| 30 tablet in 1 bottle | 43353-594-30 | Aphena Pharma Solutions - Tennessee | 26 July 2017 |
| 60 tablet in 1 bottle | 43353-594-53 | Aphena Pharma Solutions - Tennessee | 26 July 2017 |
| 90 tablet in 1 bottle | 43353-594-60 | Aphena Pharma Solutions - Tennessee | 26 July 2017 |
| 120 tablet in 1 bottle | 43353-594-70 | Aphena Pharma Solutions - Tennessee | 26 July 2017 |
| 180 tablet in 1 bottle | 43353-594-80 | Aphena Pharma Solutions - Tennessee | 26 July 2017 |
| 240 tablet in 1 bottle | 43353-594-90 | Aphena Pharma Solutions - Tennessee | 26 July 2017 |
| 30 tablet in 1 bottle | 71610-714-30 | Aphena Pharma Solutions - Tennessee | 12 June 2023 |
| 60 tablet in 1 bottle | 71610-714-53 | Aphena Pharma Solutions - Tennessee | 12 June 2023 |
| 90 tablet in 1 bottle | 71610-714-60 | Aphena Pharma Solutions - Tennessee | 12 June 2023 |
| 120 tablet in 1 bottle | 71610-714-70 | Aphena Pharma Solutions - Tennessee | 12 June 2023 |
| 180 tablet in 1 bottle | 71610-714-80 | Aphena Pharma Solutions - Tennessee | 12 June 2023 |
| 240 tablet in 1 bottle | 71610-714-90 | Aphena Pharma Solutions - Tennessee | 12 June 2023 |
| 60 tablet in 1 bottle | 71610-809-53 | Aphena Pharma Solutions - Tennessee | 22 March 2024 |
| 90 tablet in 1 bottle | 71610-809-60 | Aphena Pharma Solutions - Tennessee | 22 March 2024 |
| 120 tablet in 1 bottle | 71610-809-70 | Aphena Pharma Solutions - Tennessee | 22 March 2024 |
| 180 tablet in 1 bottle | 71610-809-80 | Aphena Pharma Solutions - Tennessee | 8 April 2024 |
| 240 tablet in 1 bottle | 71610-809-90 | Aphena Pharma Solutions - Tennessee | 8 April 2024 |
| 20 tablet in 1 bottle, plastic | 50090-3456-1 | A-S Medication Solutions | 7 July 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 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
Alternatives
Other makers and brands of Atropine and Diphenoxylate 0.025 mg/2.5 mg tablet.
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 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.