Medicine
Cotempla XR-ODT 25.9 mg orally disintegrating tablet
Cotempla XR-ODT 25.9 mg orally disintegrating tablet is a prescription medicine containing Methylphenidate for oral use, marketed by Neos Therapeutics Brands, 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 from 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Methylphenidate
- Brand
- Cotempla XR-ODT
- Strength
- 25.9 mg
- Dosage form
- Orally disintegrating tablet
- Route
- Oral
- Packs
- 5 blister pack, 30 tablets
- Marketing authorisation holder
- Neos Therapeutics Brands
- Manufacturer
- Neos Therapeutics Brands
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F). Store COTEMPLA XR-ODT bottles in a cool, dry place at 20°C to 25°C (68°F to 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F). Store COTEMPLA XR-ODT blister packages in the reusable travel case after removal from the carton.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- ATC code
- N06BA04 Methylphenidate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 June 2017
- Identifiers
- RxCUI 1926840, 1926847, 1926849 +3DailyMed set ID 33f70f58-c871-42c8-8adb-345caeafefcdNDC 70165-300Application NDA205489
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 |
|---|---|---|---|
| 5 blister pack in 1 carton / 6 tablet, orally disintegrating in 1 blister pack | 70165-300-30 | Neos Therapeutics Brands | 20 June 2017 |
| 30 tablet, orally disintegrating in 1 bottle | 70165-300-31 | Neos Therapeutics Brands | 12 October 2026 |
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 Methylphenidate 25.9 mg orally disintegrating tablet.
Other strengths and forms of Methylphenidate
Clinical summary
Methylphenidate is a central nervous system stimulant indicated for the treatment of attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults, among other approved uses. MedsAcross supplies Methylphenidate 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 MethylphenidateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ritalin prescribing information (Sandoz) · U.S. National Library of Medicine, DailyMed
- Tuzulby: European public assessment report (EPAR) · European Medicines Agency
Need Cotempla XR-ODT 25.9 mg orally disintegrating 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.