Medicine
Dicyclomine 20 mg/2 mL injection
Dicyclomine 20 mg/2 mL injection is a generic prescription medicine for intramuscular use, made by 7 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
Protect from freezing. Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Dicyclomine
- Brand
- Sold under the generic name
- Strength
- 20 mg/2 mL
- Dosage form
- Injection
- Route
- Intramuscular
- Packs
- 5 vials of 2 mL, 5 ampules of 2 mL, 10 vials of 2 mL and 7 more
- Manufacturers
- American RegentSlate Run PharmaceuticalsSomerset TherapeuticsFosun PharmaFresenius KabiHealthFirstHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store at 20° to 25°C (68° to 77°F).
- 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
- 30 December 2015
- Identifiers
- RxCUI 991065DailyMed set ID 7ad77f59-e24a-406d-95bf-3d5c6cbc3cbe, 26a94263-46c0-4938-849c-ffb396e48dd3, cbc22f25-e100-4c59-8f38-5f82113166fb +4NDC 70069-431, 0641-6173, 72266-127 +5Application ANDA214332, ANDA040465, ANDA210979 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 5 vial in 1 carton / 2 mL in 1 vial | 70069-431-05 | Somerset Therapeutics | 5 November 2024 |
| 5 ampule in 1 carton / 2 mL in 1 ampule | 70069-441-05 | Somerset Therapeutics | 5 November 2024 |
| 5 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 0517-1980-05 | American Regent | 11 September 2017 |
| 10 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 0517-1980-10 | American Regent | 11 September 2017 |
| 5 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 72266-127-05 | Fosun Pharma | 30 December 2019 |
| 5 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 63323-842-02 | Fresenius Kabi | 12 September 2019 |
| 10 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 0641-6173-10 | Hikma Pharmaceuticals | 30 December 2015 |
| 2 mL in 1 vial | 70436-147-80 | Slate Run Pharmaceuticals | 23 September 2021 |
| 5 vial, single-dose in 1 box / 2 mL in 1 vial, single-dose | 70436-147-81 | Slate Run Pharmaceuticals | 23 September 2021 |
| 5 pouch in 1 case / 1 vial, single-dose in 1 pouch / 2 mL in 1 vial, single-dose | 51662-1559-3 | HealthFirst | 19 July 2021 |
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 20 mg/2 mL injection 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.