Medicine
Adzenys XR-ODT 18.8 mg orally disintegrating tablet
Adzenys XR-ODT 18.8 mg orally disintegrating tablet is a prescription medicine containing Amphetamine for oral use, marketed by Neos Therapeutics Brands, 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°C to 25º C (68°F to 77º F). Store ADZENYS XR-ODT bottle packaging…
Key facts
- Active ingredient (INN)
- Amphetamine
- Brand
- Adzenys XR-ODT
- Strength
- 18.8 mg
- Dosage form
- Orally disintegrating tablet
- Route
- Oral
- Packs
- 30 blister pack, 30 tablets
- Marketing authorisation holder
- Neos Therapeutics Brands
- Manufacturer
- Neos Therapeutics Brands
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25º C (68°F to 77º F). Store ADZENYS XR-ODT bottle packaging in a cool, dry place at 20°C to 25º C (68°F to 77º F). Excursions permitted to 15-30º C (59-86º F). Excursions permitted to 15-30º C (59-86º F) Store ADZENYS XR-ODT blister packages in the rigid, plastic travel case provided after removal from the carton.
- 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
- 16 February 2016
- Identifiers
- RxCUI 1739803, 1739809, 1739813 +7DailyMed set ID c1179269-00b5-48ea-972d-31e614e99b7eNDC 70165-030Application NDA204326
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 blister pack in 1 carton / 6 tablet, orally disintegrating in 1 blister pack | 70165-030-30 | Neos Therapeutics Brands | 16 February 2016 |
| 30 tablet, orally disintegrating in 1 bottle | 70165-030-31 | Neos Therapeutics Brands | 1 October 2026 |
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 18.8 mg orally disintegrating 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 Adzenys XR-ODT 18.8 mg orally disintegrating 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.