Medicine
Cystadane 1 g/g powder for oral solution
Cystadane 1 g/g powder for oral solution is a prescription medicine containing Betaine for oral use, marketed by Recordati Rare Diseases, 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 room temperature, 15 to 30 ˚C (59 to 86 ˚F). Protect from moisture.
Key facts
- Active ingredient (INN)
- Betaine
- Brand
- Cystadane
- Strength
- 1 g/g
- Dosage form
- Powder for oral solution
- Route
- Oral
- Packs
- 180 g
- Marketing authorisation holder
- Recordati Rare Diseases
- Manufacturer
- Recordati Rare Diseases
- Origin register
- US FDA, United States
- Storage
- Store at room temperature, 15 to 30 ˚C (59 to 86 ˚F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AA06 Betaine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 October 1996
- Identifiers
- RxCUI 404539, 562847DailyMed set ID 31a684d0-cd98-4e46-b43a-ccbd17c41559NDC 52276-400Application NDA020576
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 |
|---|---|---|---|
| 180 g in 1 bottle | 52276-400-01 | Recordati Rare Diseases | 13 April 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.
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 Betaine 1 g/g powder for oral solution.
Clinical summary
Betaine is a methylating agent indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. It is available as powder for oral solution. MedsAcross supplies Betaine 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 BetaineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cystadane prescribing information (Recordati Rare Diseases) · U.S. National Library of Medicine, DailyMed
- Cystadane: European public assessment report (EPAR) · European Medicines Agency
- Amversio: European public assessment report (EPAR) · European Medicines Agency
Need Cystadane 1 g/g powder for 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.