Medicine
Amphetamine and Dextroamphetamine 3.125 mg/3.125 mg/3.125 mg/3.125 mg tablet
Amphetamine and Dextroamphetamine 3.125 mg/3.125 mg/3.125 mg/3.125 mg tablet is a generic prescription medicine for oral use, made by 10 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).
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
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 250 tablets and 15 more
- Manufacturers
- Aurolife PharmaIndiaGranules IndiaIndiaCamber PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaElite LaboratoriesSunrise PharmaceuticalLannettNorthStar RxRhodes PharmaceuticalsTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°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
- 19 March 2003
- Identifiers
- RxCUI 541363, 541878, 541892 +4DailyMed set ID f92497b5-baea-4760-b615-45a0b6184402, e677690f-790f-4626-ad78-097cdb6ea540, ef3590cc-49ae-44f7-85a9-7c11f58d467e +7NDC 0527-0763, 64850-503, 42858-724 +7Application ANDA215565, ANDA211352, ANDA213111 +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 | 13107-071-01 | Aurolife PharmaIndia | 27 November 2013 |
| 500 tablet in 1 bottle | 13107-071-05 | Aurolife PharmaIndia | 27 November 2013 |
| 250 tablet in 1 bottle | 13107-071-25 | Aurolife PharmaIndia | 27 November 2013 |
| 50 tablet in 1 bottle | 13107-071-50 | Aurolife PharmaIndia | 27 November 2013 |
| 1000 tablet in 1 bottle | 13107-071-99 | Aurolife PharmaIndia | 27 November 2013 |
| 100 tablet in 1 bottle | 31722-158-01 | Camber PharmaceuticalsIndia | 10 May 2021 |
| 100 tablet in 1 bottle | 70010-114-01 | Granules IndiaIndia | 28 March 2023 |
| 30 tablet in 1 bottle | 70010-114-03 | Granules IndiaIndia | 30 April 2024 |
| 100 tablet in 1 bottle, plastic | 57664-644-08 | Sun Pharmaceutical IndustriesIndia | 9 September 2003 |
| 100 tablet in 1 bottle | 64850-503-01 | Elite Laboratories | 29 December 2022 |
| 500 tablet in 1 bottle | 64850-503-05 | Elite Laboratories | 29 December 2022 |
| 30 tablet in 1 bottle | 64850-503-30 | Elite Laboratories | 29 December 2022 |
| 100 tablet in 1 bottle | 0527-0763-37 | Lannett | 8 July 2022 |
| 100 tablet in 1 bottle | 42858-724-01 | Rhodes Pharmaceuticals | 9 September 2021 |
| 100 tablet in 1 bottle | 11534-193-01 | Sunrise Pharmaceutical | 4 July 2018 |
| 1000 tablet in 1 bottle | 11534-193-03 | Sunrise Pharmaceutical | 4 July 2018 |
| 100 tablet in 1 bottle | 0555-0776-02 | Teva Pharmaceuticals | 19 March 2003 |
| 100 tablet in 1 bottle, plastic | 16714-805-01 | Northstar Rx | 9 September 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 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 tablet.
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 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.