Medicine
Dextroamphetamine 5 mg extended-release capsule
Dextroamphetamine 5 mg extended-release capsule is a generic prescription medicine for oral use, made by 3 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 controlled room temperature between 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Dextroamphetamine
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 90 capsules, 100 capsules
- Manufacturers
- Actavis PharmaAmneal Pharmaceuticals of New YorkSpecGx
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature between 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- ATC code
- N06BA02 Dextroamphetamine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 August 1976
- Identifiers
- RxCUI 884520, 884532, 884535DailyMed set ID 9e92ccc3-d81c-461d-a19f-7e9b582be357, 2ec5c30f-4eb8-48a5-83c4-236450413464, 69c40af8-3710-46bf-bd3d-137fe5eea23eNDC 45963-303, 0115-9927, 0406-8960Application ANDA203901, NDA017078, ANDA076353
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 |
|---|---|---|---|
| 90 capsule, extended release in 1 bottle | 45963-303-09 | Actavis Pharma | 19 June 2014 |
| 90 capsule, extended release in 1 bottle | 0115-9927-10 | Amneal Pharmaceuticals of New York | 2 August 1976 |
| 100 capsule, extended release in 1 bottle | 0406-8960-01 | SpecGx | 6 May 2003 |
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 2 August 1976 | 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 Dextroamphetamine 5 mg extended-release capsule.
Other strengths and forms of Dextroamphetamine
Clinical summary
Dextroamphetamine is a central nervous system stimulant indicated as an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. MedsAcross supplies 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 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
- DEXEDRINE SPANSULE prescribing information (Amneal Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Dextroamphetamine 5 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.