Medicine
Mixed Salts of a Single-Entity Amphetamine Product 3.125 mg/3.125 mg/3.125 mg/3.125 mg extended-release capsule
Mixed Salts of a Single-Entity Amphetamine Product 3.125 mg/3.125 mg/3.125 mg/3.125 mg extended-release capsule is a prescription medicine containing Amphetamine and Dextroamphetamine for oral use, marketed by SpecGx, 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, 20°C to 25°C (68°F to 77°F). Excursions permitted…
Key facts
- Active ingredient (INN)
- Amphetamine and Dextroamphetamine
- Brand
- Mixed Salts of a Single-Entity Amphetamine Product
- Strength
- 3.125 mg/3.125 mg/3.125 mg/3.125 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 100 capsules
- Marketing authorisation holder
- SpecGx
- Manufacturer
- SpecGx
- Origin register
- US FDA, United States
- Storage
- Store at room temperature, 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F).
- 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
- 1 November 2023
- Identifiers
- RxCUI 1927610, 1927617, 1927630 +1DailyMed set ID e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78NDC 0406-0805Application ANDA211546
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule, extended release in 1 bottle | 0406-0805-01 | SpecGx | 1 November 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 Mixed Salts of a Single-Entity Amphetamine Product 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.