Medicine
Dexmethylphenidate 10 mg tablet
Dexmethylphenidate 10 mg tablet is a generic prescription medicine for oral 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
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Dexmethylphenidate
- Brand
- Sold under the generic name
- Strength
- 10 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 12 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaAscend LaboratoriesIndiaLupinIndiaBryant Ranch PrepackCranbury PharmaceuticalsKVK-TechNivagen Pharmaceuticals
- 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). Protect from light and moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- ATC code
- N06BA11 Dexmethylphenidate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 November 2001
- Identifiers
- RxCUI 899518, 899548, 899557DailyMed set ID 1f2aa66a-51dc-459c-a765-5364bccd310f, 987b4983-1edc-40f1-adc9-724747080969, 830df993-db01-40df-beef-90af6b86f561 +6NDC 27808-093, 57664-379, 67877-657 +6Application ANDA207901, ANDA201231, ANDA212631 +3
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 67877-657-01 | Ascend LaboratoriesIndia | 21 July 2019 |
| 500 tablet in 1 bottle | 67877-657-05 | Ascend LaboratoriesIndia | 21 July 2019 |
| 30 tablet in 1 bottle | 67877-657-30 | Ascend LaboratoriesIndia | 21 July 2019 |
| 100 tablet in 1 bottle | 43386-861-01 | LupinIndia | 4 December 2015 |
| 100 tablet in 1 bottle | 57664-379-08 | Sun Pharmaceutical IndustriesIndia | 26 September 2013 |
| 500 tablet in 1 bottle | 57664-379-13 | Sun Pharmaceutical IndustriesIndia | 26 September 2013 |
| 1000 tablet in 1 bottle | 57664-379-18 | Sun Pharmaceutical IndustriesIndia | 26 September 2013 |
| 30 tablet in 1 bottle | 57664-379-83 | Sun Pharmaceutical IndustriesIndia | 26 September 2013 |
| 100 tablet in 1 bottle | 57664-379-88 | Sun Pharmaceutical IndustriesIndia | 26 September 2013 |
| 100 tablet in 1 bottle | 27808-093-01 | Cranbury Pharmaceuticals | 30 November 2001 |
| 100 tablet in 1 bottle | 10702-108-01 | Kvk-Tech | 4 December 2015 |
| 100 tablet in 1 bottle | 75834-328-01 | Nivagen Pharmaceuticals | 3 May 2024 |
| 100 tablet in 1 bottle, plastic | 63629-2307-1 | Bryant Ranch Prepack | 22 December 2021 |
| 100 tablet in 1 bottle, plastic | 72162-1286-1 | Bryant Ranch Prepack | 1 February 2024 |
| 100 tablet in 1 bottle | 72162-2427-1 | Bryant Ranch Prepack | 17 March 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 13 November 2001 | 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 Dexmethylphenidate 10 mg tablet.
Other strengths and forms of Dexmethylphenidate
Clinical summary
Dexmethylphenidate is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It is available as extended-release capsules and tablets for oral use. MedsAcross supplies Dexmethylphenidate 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 DexmethylphenidateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Focalin prescribing information (Sandoz) · U.S. National Library of Medicine, DailyMed
Need Dexmethylphenidate 10 mg 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.