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Medicine

Quillivant XR 300 mg/60 mL extended-release oral suspension

Methylphenidate · Oral · NextWave Pharmaceuticals
Available on requestPrescription onlyUS FDAControlled, schedule CII

Quillivant XR 300 mg/60 mL extended-release oral suspension is a prescription medicine containing Methylphenidate for oral use, marketed by NextWave Pharmaceuticals, 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 25ºC (77ºF), excursions permitted from 15ºC to 30ºC (59ºF to 86ºF).

Key facts

Active ingredient (INN)
Methylphenidate
Brand
Quillivant XR
Strength
300 mg/60 mL
Dosage form
Extended-release oral suspension
Route
Oral
Packs
1 bottle and 1 more
Marketing authorisation holder
NextWave Pharmaceuticals
Manufacturer
NextWave Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 25ºC (77ºF), excursions permitted from 15ºC to 30ºC (59ºF to 86ºF).
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
1 October 2012
Identifiers
RxCUI 1312583, 1312589DailyMed set ID c2dc2109-44a6-4797-b04e-18761dd9d45aNDC 24478-323, 24478-324, 24478-321 +1Application NDA202100

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

PackCodeLabelerMarketed since
1 bottle in 1 carton / 60 mL in 1 bottle24478-321-02NextWave Pharmaceuticals1 October 2012
1 bottle in 1 carton / 120 mL in 1 bottle24478-322-04NextWave Pharmaceuticals1 October 2012
1 bottle in 1 carton / 150 mL in 1 bottle24478-323-05NextWave Pharmaceuticals1 October 2012
1 bottle in 1 carton / 180 mL in 1 bottle24478-324-06NextWave Pharmaceuticals4 January 2013

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

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 Quillivant XR 300 mg/60 mL extended-release oral suspension 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.