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United States· US:31722-355_c797bf2e-e9b6-4f7f-b12c-c514667107f0

LISDEXAMFETAMINE DIMESYLATE

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

In shortageATC N06BAOrange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedLISDEXAMFETAMINE DIMESYLATEATCN06BAREGISTER NO.US:31722-355_c797bf2e…PACKS LISTED1CHECKEDSeptember 12, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Lisdexamfetamine dimesylate
Manufacturer
Camber Pharmaceuticals, 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
    3172235501
    100 CAPSULE in 1 BOTTLE (31722-355-01)

Regulatory notes

UNII (FDA substance ID)
SJT761GEGS
LISDEXAMFETAMINE DIMESYLATE
RxCUI 673579
Orange Book
A217442
ABABABABABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Lisdexamfetamine Dimesylate Capsule

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/bb53946d-fb55-483f-9832-a9fde8143fd4
GET /v1/drugs/bb53946d-fb55-483f-9832-a9fde8143fd4?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": "31722-355_c797bf2e-e9b6-4f7f-b12c-c514667107f0",
  "productndc": "31722-355",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "217442",
    "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": "ANDA217442",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lisdexamfetamine dimesylate",
  "start_marketing_date": "20240909",
  "active_numerator_strength": "60"
}

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.