Medicine
Amphetamine 5 mg tablet
Amphetamine 5 mg tablet is a generic prescription medicine for oral use, made by 11 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 between 15oC and 30oC…
Key facts
- Active ingredient (INN)
- Amphetamine
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets and 13 more
- Manufacturers
- Aurolife PharmaIndiaDr. Reddy's LaboratoriesIndiaGranules IndiaIndiaBryant Ranch PrepackAmici PharmaAmneal Pharmaceuticals NYEpic PharmaLannettSolco HealthcareSpecGx
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15oC and 30oC (59oF and 86oF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- ATC code
- N06BA01 Amphetamine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 March 2018
- Identifiers
- RxCUI 884655, 1600695DailyMed set ID ad4ce013-331b-4359-898f-bac97d64874f, 85a015a7-a1a0-4b04-8bc4-7aacd0c84742, c00bbade-3dc8-422b-8cff-f85db408bdfc +13NDC 72162-1368, 0527-2524, 63629-2079 +13Application ANDA211861, ANDA212901, ANDA213583 +6
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 tablet in 1 bottle | 13107-259-01 | Aurolife PharmaIndia | 31 January 2019 |
| 100 tablet in 1 bottle | 43598-897-01 | Dr. Reddy's LaboratoriesIndia | 1 March 2020 |
| 100 tablet in 1 bottle | 70010-040-01 | Granules IndiaIndia | 15 August 2019 |
| 100 tablet in 1 bottle | 69292-106-01 | Amici Pharma | 15 June 2026 |
| 100 tablet in 1 bottle | 69238-1563-1 | Amneal Pharmaceuticals NY | 28 September 2018 |
| 100 tablet in 1 bottle | 42806-029-01 | Epic Pharma | 18 September 2020 |
| 100 tablet in 1 bottle | 0527-2524-37 | Lannett | 1 June 2020 |
| 100 tablet in 1 bottle | 43547-457-10 | Solco Healthcare | 2 April 2020 |
| 100 tablet in 1 bottle | 0406-1219-01 | SpecGx | 28 February 2021 |
| 30 tablet in 1 bottle | 52536-057-03 | Wilshire Pharmaceuticals | 7 January 2021 |
| 100 tablet in 1 bottle | 63629-1115-1 | Bryant Ranch Prepack | 30 July 2020 |
| 100 tablet in 1 bottle | 63629-2079-1 | Bryant Ranch Prepack | 2 April 2024 |
| 100 tablet in 1 bottle | 63629-2499-1 | Bryant Ranch Prepack | 29 March 2018 |
| 100 tablet in 1 bottle | 72162-1087-1 | Bryant Ranch Prepack | 5 April 2024 |
| 100 tablet in 1 bottle | 72162-1368-1 | Bryant Ranch Prepack | 25 January 2024 |
| 30 tablet in 1 bottle | 72162-1612-3 | Bryant Ranch Prepack | 7 January 2021 |
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 27 January 2016 | 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 5 mg tablet.
Other strengths and forms of Amphetamine
Clinical summary
Amphetamine is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. It is available as tablets, orally disintegrating tablets and extended-release tablets. MedsAcross supplies Amphetamine 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 AmphetamineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Amphetamine Extended-Release prescribing information (Neos Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Amphetamine 5 mg tablet 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.