United States· US:0781-2480_816921ba-16ab-4cdc-86e7-f21a86b03d1a

Lisdexamfetamine dimesylate

A centrally acting sympathomimetics product containing lisdexamfetamine dimesylate, registered in United States by Sandoz Inc.

In shortageATC N06BAOrange BookUS label

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

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: Lisdexamfetamine dimesylate
Manufacturer: Sandoz Inc
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
0781248001
100 CAPSULE in 1 BOTTLE (0781-2480-01)

Regulatory notes

UNII (FDA substance ID)

SJT761GEGS

LISDEXAMFETAMINE DIMESYLATE

RxCUI 673579

Orange Book

A202836

ABABABABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Lisdexamfetamine Dimesylate Tablet, Chewable

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.

All lisdexamfetamine dimesylate 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/b8a646f5-c6f9-4945-9a3c-9650db5c83dd
GET /v1/drugs/b8a646f5-c6f9-4945-9a3c-9650db5c83dd?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": "0781-2480_816921ba-16ab-4cdc-86e7-f21a86b03d1a",
  "productndc": "0781-2480",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "202836",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Jul 26, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Jul 26, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Jul 26, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "004",
        "approval_date": "Jul 26, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "005",
        "approval_date": "Jul 26, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "70MG",
        "product_no": "006",
        "approval_date": "Jul 26, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "007",
        "approval_date": "Dec 26, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LISDEXAMFETAMINE DIMESYLATE",
  "shortage_reason": "Lisdexamfetamine Dimesylate Tablet, Chewable",
  "shortage_status": "current",
  "proprietary_name": "Lisdexamfetamine dimesylate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202836",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lisdexamfetamine dimesylate",
  "start_marketing_date": "20250916",
  "active_numerator_strength": "60"
}

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