United States· US:0054-0371_e1f9cc7f-de87-407e-b65b-61bc5044ce55
Lisdexamfetamine Dimesylate
A medicinal product containing lisdexamfetamine dimesylate, registered in United States by Hikma Pharmaceuticals USA Inc..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- lisdexamfetamine dimesylate
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 12, 2026
Packs & prices · 1
- ndc110054037125100 CAPSULE in 1 BOTTLE (0054-0371-25)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Lisdexamfetamine dimesylate in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwedenAdixemin 30 mg Kapsel, hårdSTADA Arzneimittel AG
- FinlandAdixeminSTADA Arzneimittel AG
- NorwayAduvanz2care4 ApS
- IcelandAdixeminSTADA Arzneimittel AG
- United KingdomElvanse 30mg capsulesShire Pharmaceuticals Ltd
- CanadaAPO-LISDEXAMFETAMINE CAPSULESAPOTEX INC
- PolandEldefabG.L. Pharma GmbH
- IrelandLisdexamfetamine dimesylate Rowex 30 mg hard capsulesRowex Limited,
Authorised across Europe · EMA
The same active substance is authorised in 26 EEA countries. Names it is sold under:
- Austria · Elvanse, Elvanse Erwachsene
- Belgium · Elvanse
- Czechia · Livizux
- Germany · Elvanse, Lisdex- Aristo
- Denmark · Adixemin, Aduvanz
- Estonia · Adixemin, Elvanse
- Spain · Elvanse, Elvanse Adultos
- Finland · Dexhility, Elvanse
- France · Fobettin, Xurta
- United Kingdom (Northern Ireland) · Elvanse, Elvanse Adult
- Hungary · Livizux
- Ireland · Lisdexamfetamine Dimesylate Rowex, Tyvense
- Iceland · Amdex, Dexhility
- Italy · Minalix
- Lithuania · Adixemin
- Luxembourg · Elvanse
- Latvia · Adixemin, Lisdexamfetamine Zentiva
- Malta · Lisdexamfetamin, Lisdexamfetamine Aristo Aristo
- Netherlands · Elvanse, Lisdexamfetamine Aristo Aristo
- Norway · Aduvanz, Balidax
- Poland · Eldefab, Elvanse
- Portugal · Dimesilato De Lisdexanfetamina Teva, Dimesilato De Lisdexanfetamina Zentiva
- Romania · Lisdexamfetaminä Stada
- Sweden · Balidax, Dexhility
- Slovenia · Lisdeksamfetamin Aristo, Lisdeksamfetamin Aristo Aristo
- Slovakia · Livizux
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/efe210ae-d4e1-47e4-b0dc-2dd631ba3a8e GET /v1/drugs/efe210ae-d4e1-47e4-b0dc-2dd631ba3a8e?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"livertox": {
"summary": null,
"livertox_id": null,
"hepatotoxicity_score": 1
},
"productid": "0054-0371_e1f9cc7f-de87-407e-b65b-61bc5044ce55",
"productndc": "0054-0371",
"dosage_form": "CAPSULE",
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LISDEXAMFETAMINE DIMESYLATE",
"proprietary_name": "Lisdexamfetamine Dimesylate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202827",
"marketing_category": "ANDA",
"nonproprietary_name": "lisdexamfetamine dimesylate",
"start_marketing_date": "20230825",
"active_numerator_strength": "30"
}See everything about lisdexamfetamine dimesylate.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.