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MedsAcross

Medicine

Methylphenidate 20 mg tablet

Available on requestPrescription onlyUS FDAControlled, schedule CIIGeneric name

Methylphenidate 20 mg tablet is a generic prescription medicine for oral use, made by 13 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

Available on request

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 15ºC and…

Key facts

Active ingredient (INN)
Methylphenidate
Brand
Sold under the generic name
Strength
20 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 10 blister pack, 500 tablets and 26 more
Manufacturers
Sun Pharmaceutical IndustriesIndiaAscend LaboratoriesIndiaCamber PharmaceuticalsIndiaAccord HealthcareIndiaAurolife PharmaIndiaLupinIndiaBryant Ranch PrepackKVK-TechSpecGxXLCare Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15ºC and 30ºC (59ºF and 86ºF). 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, 1091497 +2DailyMed set ID ec8a8896-077d-4dee-9e10-97172512c5ed, 981a2ad8-33f7-4678-9162-9df9685bd4a6, 4cc16009-44ad-4055-ac76-efa282f1ff47 +13NDC 43386-575, 0406-1146, 75834-326 +13Application ANDA207884, ANDA040300, ANDA208737 +9

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.

PackCodeLabelerMarketed since
100 tablet in 1 bottle16729-480-01Accord HealthcareIndia17 December 2020
100 tablet in 1 bottle67877-618-01Ascend LaboratoriesIndia6 October 2019
10 blister pack in 1 carton / 1 tablet in 1 blister pack67877-618-33Ascend LaboratoriesIndia6 October 2019
100 tablet in 1 bottle13107-382-01Aurolife PharmaIndia11 April 2017
100 tablet in 1 bottle31722-175-01Camber PharmaceuticalIndia1 October 2015
500 tablet in 1 bottle31722-175-05Camber PharmaceuticalIndia1 October 2015
100 tablet in 1 bottle43386-575-01LupinIndia20 January 2016
100 tablet in 1 bottle57664-230-08Sun Pharmaceutical IndustriesIndia16 August 2013
500 tablet in 1 bottle57664-230-13Sun Pharmaceutical IndustriesIndia16 August 2013
1000 tablet in 1 bottle57664-230-18Sun Pharmaceutical IndustriesIndia16 August 2013
30 tablet in 1 bottle57664-230-83Sun Pharmaceutical IndustriesIndia16 August 2013
100 tablet in 1 bottle57664-230-88Sun Pharmaceutical IndustriesIndia16 August 2013
100 tablet in 1 bottle10702-076-01KVK-Tech9 June 2015
60 tablet in 1 bottle10702-076-06KVK-Tech9 June 2015
100 tablet in 1 bottle10702-102-01Kvk-Tech11 May 2017
100 tablet in 1 bottle, plastic0115-1802-01Amneal Pharmaceuticals of New York7 April 2014
100 tablet in 1 bottle75834-326-01Nivagen Pharmaceuticals16 April 2024
100 tablet in 1 bottle43547-488-10Solco Healthcare US,LLC1 July 2020
100 tablet in 1 bottle0406-1146-01SpecGx27 November 1998
1000 tablet in 1 bottle0406-1146-10SpecGx27 November 1998
100 tablet in 1 bottle72865-124-01XLCare Pharmaceuticals26 February 2020
500 tablet in 1 bottle72865-124-05XLCare Pharmaceuticals26 February 2020
30 tablet in 1 bottle71335-1219-1Bryant Ranch Prepack31 October 2024
100 tablet in 1 bottle71335-1219-2Bryant Ranch Prepack31 October 2024
90 tablet in 1 bottle71335-1219-3Bryant Ranch Prepack24 April 2019
60 tablet in 1 bottle71335-1219-4Bryant Ranch Prepack24 April 2019
120 tablet in 1 bottle71335-1219-5Bryant Ranch Prepack31 October 2024
100 tablet in 1 bottle72162-2087-1Bryant Ranch Prepack3 April 2024
100 tablet in 1 bottle72162-2430-1Bryant Ranch Prepack18 November 2024

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 5 December 1955Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS 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 Methylphenidate 20 mg tablet.

Compare 1

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 Methylphenidate

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Methylphenidate 20 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.