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Medicine

Methylphenidate 5 mg/5 mL oral solution

Available on requestPrescription onlyUS FDAControlled, schedule CIIGeneric name

Methylphenidate 5 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 9 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° to 25°C (68° to 77°F), with excursions permitted between 15° to…

Key facts

Active ingredient (INN)
Methylphenidate
Brand
Sold under the generic name
Strength
5 mg/5 mL
Dosage form
Oral solution
Route
Oral
Packs
500 mL, 250 mL and 9 more
Manufacturers
Ascend LaboratoriesIndiaLupinIndiaBryant Ranch PrepackAscent PharmaceuticalsCranbury PharmaceuticalsEywa PharmaKVK-TechPatrin PharmaQuagen Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86°F).
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
4 March 2015
Identifiers
RxCUI 1091133, 1091341DailyMed set ID 2cf1b26b-199d-4c7f-ab64-4805a9def2cc, b9c31526-d486-433c-9b3c-7a12765afe94, e817377f-bc72-415a-acd2-7136746b2479 +8NDC 10702-163, 72162-1992, 27808-058 +8Application ANDA207485, ANDA210139, ANDA091601 +5

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
500 mL in 1 bottle67877-602-91Ascend LaboratoriesIndia1 April 2020
500 mL in 1 bottle43386-930-05LupinIndia15 December 2015
500 mL in 1 bottle43602-177-05Ascent Pharmaceuticals29 January 2021
250 mL in 1 bottle43602-177-25Ascent Pharmaceuticals29 January 2021
500 mL in 1 bottle, plastic27808-058-01Cranbury Pharmaceuticals4 March 2015
500 mL in 1 bottle71930-024-52Eywa Pharma29 March 2019
500 mL in 1 bottle10702-163-50KVK-Tech23 January 2017
500 mL in 1 bottle39328-054-50Patrin Pharma23 April 2020
500 mL in 1 bottle, plastic70752-131-14Quagen Pharmaceuticals4 June 2020
500 mL in 1 bottle63629-1175-1Bryant Ranch Prepack26 July 2022
500 mL in 1 bottle72162-1992-5Bryant Ranch Prepack3 April 2024
500 mL in 1 bottle, plastic72162-2040-5Bryant Ranch Prepack3 April 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 5 mg/5 mL oral solution.

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 5 mg/5 mL oral solution 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.