Medicine
Methylphenidate 5 mg tablet
Methylphenidate 5 mg tablet is a generic prescription medicine for oral use, made by 14 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 15°C and 30°C (59°F…
Key facts
- Active ingredient (INN)
- Methylphenidate
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 10 blister pack, 500 tablets and 23 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaAscend LaboratoriesIndiaCamber PharmaceuticalsIndiaAccord HealthcareIndiaAurolife PharmaIndiaLupinIndiaBryant Ranch PrepackSpecGxXLCare PharmaceuticalsAmerican Health Packaging
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C and 30°C (59°F and 86°F). Protect from light.
- 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
- 27 November 1998
- Identifiers
- RxCUI 1091150, 1091392, 1091497DailyMed set ID 1bf37f9f-29cf-4b09-9c81-eb369e35a042, 371346d1-ac7e-491c-a010-ad29cb3d567a, 1c7d7e6c-4e96-4d18-8dca-203ef50766ec +14NDC 10702-100, 72162-2428, 63629-1172 +14Application ANDA206932, ANDA208737, ANDA090710 +8
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 | 16729-478-01 | Accord HealthcareIndia | 23 December 2020 |
| 100 tablet in 1 bottle | 67877-616-01 | Ascend LaboratoriesIndia | 6 October 2019 |
| 10 blister pack in 1 carton / 1 tablet in 1 blister pack | 67877-616-33 | Ascend LaboratoriesIndia | 6 October 2019 |
| 100 tablet in 1 bottle | 13107-380-01 | Aurolife PharmaIndia | 11 April 2017 |
| 100 tablet in 1 bottle | 31722-173-01 | Camber PharmaceuticalIndia | 1 October 2015 |
| 500 tablet in 1 bottle | 31722-173-05 | Camber PharmaceuticalIndia | 1 October 2015 |
| 100 tablet in 1 bottle | 43386-573-01 | LupinIndia | 20 January 2016 |
| 100 tablet in 1 bottle | 57664-228-08 | Sun Pharmaceutical IndustriesIndia | 16 August 2013 |
| 500 tablet in 1 bottle | 57664-228-13 | Sun Pharmaceutical IndustriesIndia | 16 August 2013 |
| 1000 tablet in 1 bottle | 57664-228-18 | Sun Pharmaceutical IndustriesIndia | 16 August 2013 |
| 30 tablet in 1 bottle | 57664-228-83 | Sun Pharmaceutical IndustriesIndia | 16 August 2013 |
| 100 tablet in 1 bottle | 57664-228-88 | Sun Pharmaceutical IndustriesIndia | 16 August 2013 |
| 100 tablet in 1 bottle, plastic | 0115-1800-01 | Amneal Pharmaceuticals of New York | 7 April 2014 |
| 100 tablet in 1 bottle | 10702-100-01 | Kvk-Tech | 11 May 2017 |
| 100 tablet in 1 bottle | 75834-324-01 | Nivagen Pharmaceuticals | 16 April 2024 |
| 100 tablet in 1 bottle | 43547-486-10 | Solco Healthcare US,LLC | 1 July 2020 |
| 100 tablet in 1 bottle | 0406-1142-01 | SpecGx | 27 November 1998 |
| 1000 tablet in 1 bottle | 0406-1142-10 | SpecGx | 27 November 1998 |
| 100 tablet in 1 bottle | 72865-122-01 | XLCare Pharmaceuticals | 26 February 2020 |
| 500 tablet in 1 bottle | 72865-122-05 | XLCare Pharmaceuticals | 26 February 2020 |
| 100 tablet in 1 bottle | 63629-1172-1 | Bryant Ranch Prepack | 16 August 2013 |
| 100 tablet in 1 bottle | 72162-1636-1 | Bryant Ranch Prepack | 16 August 2013 |
| 100 tablet in 1 bottle | 72162-2019-1 | Bryant Ranch Prepack | 3 April 2024 |
| 60 tablet in 1 bottle | 72162-2019-6 | Bryant Ranch Prepack | 3 April 2024 |
| 100 tablet in 1 bottle | 72162-2428-1 | Bryant Ranch Prepack | 18 November 2024 |
| 30 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 68084-805-21 | American Health Packaging | 30 September 2014 |
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 5 mg 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 Methylphenidate 5 mg tablet for your hospital or patient?
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