Medicine
Dicyclomine 10 mg/5 mL oral solution
Dicyclomine 10 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 4 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). Protect from excessive heat.
Key facts
- Active ingredient (INN)
- Dicyclomine
- Brand
- Sold under the generic name
- Strength
- 10 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 473 mL, 72 mL and 2 more
- Manufacturers
- Atlantic BiologicalsHikma PharmaceuticalsNovitium PharmaPar Health
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from excessive heat.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A03AA07 Dicyclomine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 June 2005
- Identifiers
- RxCUI 991082DailyMed set ID bb099db9-f635-4a64-8892-6236971dec45, b0911994-0b36-439d-8247-5d885a899421, 2f89e438-6a8a-917e-e063-6294a90a1c23 +1NDC 0603-1161, 70954-261, 17856-2261 +1Application ANDA040169, ANDA214721, ANDA212286
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 |
|---|---|---|---|
| 473 mL in 1 bottle | 0054-0622-63 | Hikma Pharmaceuticals | 22 May 2020 |
| 473 mL in 1 bottle | 70954-261-10 | Novitium Pharma | 23 April 2021 |
| 473 mL in 1 bottle, plastic | 0603-1161-58 | Par Health | 23 June 2005 |
| 72 mL in 1 box, unit-dose | 17856-2261-1 | Atlantic Biologicals | 4 March 2025 |
| 72 mL in 1 box, unit-dose | 17856-2261-2 | Atlantic Biologicals | 4 March 2025 |
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 11 May 1950 | 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 Dicyclomine
Clinical summary
Dicyclomine is an anticholinergic indicated for the treatment of patients with functional bowel/irritable bowel syndrome. It is available as tablets, capsules and injection for oral and intramuscular use. MedsAcross supplies Dicyclomine 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 DicyclomineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Dicyclomine hydrochloride prescribing information (Advagen Pharma) · U.S. National Library of Medicine, DailyMed
Need Dicyclomine 10 mg/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.