Medicine
Diclegis 10 mg/10 mg delayed-release tablet
Diclegis 10 mg/10 mg delayed-release tablet is a prescription medicine containing Doxylamine and Pyridoxine for oral use, marketed by Duchesnay, 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°C to 25°C (68°F to 77°F), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Doxylamine and Pyridoxine
- Brand
- Diclegis
- Strength
- 10 mg/10 mg
- Dosage form
- Delayed-release tablet
- Route
- Oral
- Packs
- 100 tablets
- Marketing authorisation holder
- Duchesnay
- Manufacturer
- Duchesnay
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Keep bottle tightly closed and protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 May 2013
- Identifiers
- RxCUI 1375948, 1375954DailyMed set ID 8bde08f6-e8bd-4e90-baa7-82e01876a86aNDC 55494-100Application NDA021876
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, delayed release in 1 bottle | 55494-100-10 | Duchesnay | 15 May 2013 |
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 30 July 1956 | 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 Doxylamine and Pyridoxine 10 mg/10 mg delayed-release tablet.
Other strengths and forms of Doxylamine and Pyridoxine
Clinical summary
Doxylamine and Pyridoxine is a fixed-dose combination of an antihistamine and a vitamin B6 analog indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. MedsAcross supplies Doxylamine and Pyridoxine 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 Doxylamine and PyridoxineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Doxylamine succinate and pyridoxine hydrochloride prescribing information (Analog Pharma) · U.S. National Library of Medicine, DailyMed
Need Diclegis 10 mg/10 mg delayed-release 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.