Medicine
Amphetamine and Dextroamphetamine 3.125 mg/3.125 mg/3.125 mg/3.125 mg extended-release capsule
Amphetamine and Dextroamphetamine 3.125 mg/3.125 mg/3.125 mg/3.125 mg extended-release capsule is a generic prescription medicine for oral use, made by 2 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 room temperature, 20ºC to 25ºC (68ºF to 77ºF). Excursions permitted…
Key facts
- Active ingredient (INN)
- Amphetamine and Dextroamphetamine
- Brand
- Sold under the generic name
- Strength
- 3.125 mg/3.125 mg/3.125 mg/3.125 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 100 capsules
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at room temperature, 20ºC to 25ºC (68ºF to 77ºF). Excursions permitted between 15ºC to 30ºC (59ºF 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
- 10 October 2023
- Identifiers
- RxCUI 1927610, 1927617, 1927630 +1DailyMed set ID 30e515c3-a18f-499a-87c4-be8d64cfdbc6, 5e84ef60-3050-40d9-9f14-66b85d289e17NDC 57664-950, 0480-3683Application ANDA215997, ANDA210876
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 capsule, extended release in 1 bottle | 57664-950-88 | Sun Pharmaceutical IndustriesIndia | 1 February 2024 |
| 100 capsule, extended release in 1 bottle | 0480-3683-01 | Teva Pharmaceuticals | 10 October 2023 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 19 January 1960 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 3.125 mg/3.125 mg/3.125 mg/3.125 mg extended-release capsule.
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 DextroamphetamineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Adderall XR prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Amphetamine and Dextroamphetamine 3.125 mg/3.125 mg/3.125 mg/3.125 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.