Medicine
Dextroamphetamine 5 mg/5 mL oral solution
Dextroamphetamine 5 mg/5 mL oral solution 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 20° to 25°C (68° to 77°F), excursions permitted from 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Dextroamphetamine
- Brand
- Sold under the generic name
- Strength
- 5 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 473 mL
- Manufacturers
- Bryant Ranch PrepackCranbury PharmaceuticalsPrasco Laboratories
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted from 15° to 30°C (59° to 86°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
- 31 May 2013
- Identifiers
- RxCUI 884522DailyMed set ID 76da9845-2ce1-49a5-9bf3-6a550d623172, 94674695-aa8a-3150-e053-2995a90a445f, 7658071e-ee2c-4d23-94ce-1906959ec036NDC 72162-2043, 66993-359, 27808-085Application ANDA203644, ANDA040776
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 |
|---|---|---|---|
| 473 mL in 1 bottle, plastic | 27808-085-01 | Cranbury Pharmaceuticals | 31 May 2013 |
| 473 mL in 1 bottle, plastic | 72162-2043-2 | Bryant Ranch Prepack | 3 April 2024 |
| 473 mL in 1 bottle, plastic | 66993-359-57 | Prasco Laboratories | 15 May 2014 |
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/5 mL oral solution.
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/5 mL oral solution 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.