United States· US:43547-602_c17f13ef-4b2e-4b45-aff9-e79a2e8a7d53

Lisdexamfetamine dimesylate

A centrally acting sympathomimetics product containing lisdexamfetamine dimesylate capsules, registered in United States by Solco Healthcare US,LLC.

In shortageATC N06BAOrange BookUS label

Checked against FDA National Drug Code directory (United States) on September 12, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about lisdexamfetamine dimesylate capsulesAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)

Active substance: Lisdexamfetamine dimesylate capsules
Manufacturer: Solco Healthcare US,LLC
Country: United States (US)
ATC code: N06BA
ATC class: Centrally acting sympathomimetics
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: September 12, 2026

Packs & prices · 1

ndc11
4354760210
100 CAPSULE in 1 BOTTLE (43547-602-10)

Regulatory notes

UNII (FDA substance ID)

SJT761GEGS

LISDEXAMFETAMINE DIMESYLATE

RxCUI 673579

Orange Book

A216266

ABABABABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Lisdexamfetamine Dimesylate Capsule

Same medicine, other countries

Lisdexamfetamine dimesylate capsules in 15 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All lisdexamfetamine dimesylate capsules products

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/d8d545c3-e232-48c3-aad9-3ec82f4819a1
GET /v1/drugs/d8d545c3-e232-48c3-aad9-3ec82f4819a1?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.

{
  "unii": {
    "unii": "SJT761GEGS",
    "rxcui": "673579",
    "inchikey": "CETWSOHVEGTIBR-FORAGAHYSA-N",
    "display_name": "LISDEXAMFETAMINE DIMESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 1
  },
  "spl_meta": {
    "6740a621-9bec-4178-a4fc-a3fc89f34e0a": {
      "match": "brand_token",
      "title": "LISDEXAMFETAMINE DIMESYLATE CAPSULE [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "7",
      "published_date": "2026-05-28"
    }
  },
  "productid": "43547-602_c17f13ef-4b2e-4b45-aff9-e79a2e8a7d53",
  "productndc": "43547-602",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "216266",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Aug 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Aug 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Aug 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "004",
        "approval_date": "Aug 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "005",
        "approval_date": "Aug 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "006",
        "approval_date": "Aug 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "70MG",
        "product_no": "007",
        "approval_date": "Aug 25, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LISDEXAMFETAMINE DIMESYLATE",
  "shortage_reason": "Lisdexamfetamine Dimesylate Capsule",
  "shortage_status": "current",
  "proprietary_name": "Lisdexamfetamine dimesylate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216266",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lisdexamfetamine dimesylate capsules",
  "start_marketing_date": "20230826",
  "active_numerator_strength": "10"
}

API reference MCP server Plans

See everything about lisdexamfetamine dimesylate capsules.

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.

Try it free Open in the console