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Medicine

Adderall XR 3.75 mg/3.75 mg/3.75 mg/3.75 mg extended-release capsule

Amphetamine and Dextroamphetamine · Oral · Takeda Pharmaceuticals
Available on requestPrescription onlyUS FDAControlled, schedule CII

Adderall XR 3.75 mg/3.75 mg/3.75 mg/3.75 mg extended-release capsule is a prescription medicine containing Amphetamine and Dextroamphetamine for oral use, marketed by Takeda 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 room temperature, 20 to 25ºC (68 to 77ºF). Excursions permitted to 15…

Key facts

Active ingredient (INN)
Amphetamine and Dextroamphetamine
Brand
Adderall XR
Strength
3.75 mg/3.75 mg/3.75 mg/3.75 mg
Dosage form
Extended-release capsule
Route
Oral
Packs
100 capsules
Marketing authorisation holder
Takeda Pharmaceuticals
Manufacturer
Takeda Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at room temperature, 20 to 25ºC (68 to 77ºF). Excursions permitted to 15 to 30ºC (59 to 86ºF).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Schedule CII
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
22 May 2002
Identifiers
RxCUI 861221, 861222, 861223 +7DailyMed set ID aff45863-ffe1-4d4f-8acf-c7081512a6c0NDC 54092-385Application NDA021303

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
100 capsule, extended release in 1 bottle54092-385-01Takeda Pharmaceuticals22 May 2002

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 19 January 1960Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
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 Amphetamine and Dextroamphetamine 3.75 mg/3.75 mg/3.75 mg/3.75 mg extended-release capsule.

Compare all 2

Other strengths and forms of Amphetamine and Dextroamphetamine

Clinical summary

Amphetamine and Dextroamphetamine is a fixed-dose combination medicine indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. MedsAcross supplies Amphetamine and Dextroamphetamine 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 Amphetamine and Dextroamphetamine

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

Data sources

Need Adderall XR 3.75 mg/3.75 mg/3.75 mg/3.75 mg extended-release capsule 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.