Medicine
Azstarys 5.2 mg/26.1 mg capsule
Azstarys 5.2 mg/26.1 mg capsule is a prescription medicine containing Dexmethylphenidate and Serdexmethylphenidate for oral use, marketed by Commave Sub, 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 to…
Key facts
- Active ingredient (INN)
- Dexmethylphenidate and Serdexmethylphenidate
- Brand
- Azstarys
- Strength
- 5.2 mg/26.1 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules
- Marketing authorisation holder
- Commave Sub
- Manufacturer
- Commave Sub
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 July 2021
- Identifiers
- RxCUI 2562186, 2562187, 2562191 +3DailyMed set ID 00b5e716-5564-4bbd-acaf-df2bc45a5663NDC 65038-286Application NDA212994
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 capsule in 1 bottle, plastic | 65038-286-99 | Commave Sub | 16 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 2 March 2021 | 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 Dexmethylphenidate and Serdexmethylphenidate
Clinical summary
Dexmethylphenidate and Serdexmethylphenidate is a fixed-dose combination medicine indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. It is available as capsules for oral use. MedsAcross supplies Dexmethylphenidate and Serdexmethylphenidate 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 Dexmethylphenidate and SerdexmethylphenidateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- AZSTARYS prescribing information (Commave Sub) · U.S. National Library of Medicine, DailyMed
Need Azstarys 5.2 mg/26.1 mg capsule 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.