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Medicine

Amphetamine and Dextroamphetamine 7.5 mg/7.5 mg/7.5 mg/7.5 mg tablet

Available on requestPrescription onlyUS FDAControlled, schedule CIIGeneric name

Amphetamine and Dextroamphetamine 7.5 mg/7.5 mg/7.5 mg/7.5 mg tablet is a generic prescription medicine for oral use, made by 15 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

Available on request

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
7.5 mg/7.5 mg/7.5 mg/7.5 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 500 tablets, 250 tablets and 25 more
Manufacturers
Aurolife PharmaIndiaGranules IndiaIndiaCamber PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaBryant Ranch PrepackElite LaboratoriesSunrise PharmaceuticalEpic PharmaLannettNorthStar Rx
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
11 February 2002
Identifiers
RxCUI 541363, 541878, 541892 +4DailyMed set ID 430cccec-1679-4225-8c86-92d746153b38, 72ddd1c9-ddbd-4c95-acd9-003189a353a3, a582d57f-d191-4ca5-b105-585b2d8a0e3e +13NDC 31722-164, 0406-8894, 13107-074 +13Application ANDA213709, ANDA040440, ANDA202424 +10

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.

PackCodeLabelerMarketed since
100 tablet in 1 bottle13107-074-01Aurolife PharmaIndia27 November 2013
500 tablet in 1 bottle13107-074-05Aurolife PharmaIndia27 November 2013
250 tablet in 1 bottle13107-074-25Aurolife PharmaIndia27 November 2013
50 tablet in 1 bottle13107-074-50Aurolife PharmaIndia27 November 2013
1000 tablet in 1 bottle13107-074-99Aurolife PharmaIndia27 November 2013
100 tablet in 1 bottle31722-164-01Camber PharmaceuticalsIndia10 May 2021
100 tablet in 1 bottle70010-117-01Granules IndiaIndia28 March 2023
30 tablet in 1 bottle70010-117-03Granules IndiaIndia30 April 2024
100 tablet in 1 bottle, plastic57664-647-08Sun Pharmaceutical IndustriesIndia9 September 2003
100 tablet in 1 bottle64850-506-01Elite Laboratories29 December 2022
500 tablet in 1 bottle64850-506-05Elite Laboratories29 December 2022
30 tablet in 1 bottle64850-506-30Elite Laboratories29 December 2022
100 tablet in 1 bottle, plastic42806-345-01Epic Pharma17 August 2018
100 tablet in 1 bottle0527-0766-37Lannett8 July 2022
100 tablet in 1 bottle72516-011-01Oryza Pharmaceuticals19 October 2020
100 tablet in 1 bottle42858-727-01Rhodes Pharmaceuticals9 September 2021
100 tablet in 1 bottle0185-2099-01Sandoz16 November 2021
100 tablet in 1 bottle0406-8894-01SpecGx7 October 2003
100 tablet in 1 bottle11534-196-01Sunrise Pharmaceutical4 July 2018
1000 tablet in 1 bottle11534-196-03Sunrise Pharmaceutical4 July 2018
100 tablet in 1 bottle0555-0974-02Teva Pharmaceuticals11 February 2002
60 tablet in 1 bottle71335-1081-1Bryant Ranch Prepack14 January 2019
90 tablet in 1 bottle71335-1081-2Bryant Ranch Prepack31 October 2024
30 tablet in 1 bottle71335-1081-3Bryant Ranch Prepack25 February 2019
60 tablet in 1 bottle71335-2070-1Bryant Ranch Prepack25 April 2022
90 tablet in 1 bottle71335-2070-2Bryant Ranch Prepack25 April 2022
30 tablet in 1 bottle71335-2070-3Bryant Ranch Prepack25 April 2022
100 tablet in 1 bottle, plastic16714-808-01Northstar Rx9 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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 19 January 1960Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 7.5 mg/7.5 mg/7.5 mg/7.5 mg tablet.

Compare all 2

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 Dextroamphetamine

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Amphetamine and Dextroamphetamine 7.5 mg/7.5 mg/7.5 mg/7.5 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.