Lisdexamfetamine Dimesylate

In shortageOrange BookUNIISPLATC N06BA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN06BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0054037025
100 CAPSULE in 1 BOTTLE (0054-0370-25)

Annotations

UNII (FDA Substance ID)

SJT761GEGS

LISDEXAMFETAMINE DIMESYLATE

RxCUI 673579

Orange Book

A202827

ABABABABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Lisdexamfetamine Dimesylate Capsule

Raw payload (JSON)

{
  "unii": {
    "unii": "SJT761GEGS",
    "rxcui": "673579",
    "inchikey": "CETWSOHVEGTIBR-FORAGAHYSA-N",
    "display_name": "LISDEXAMFETAMINE DIMESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "0054-0370_e1f9cc7f-de87-407e-b65b-61bc5044ce55",
  "productndc": "0054-0370",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "202827",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Aug 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Aug 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Aug 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "004",
        "approval_date": "Aug 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "005",
        "approval_date": "Aug 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "70MG",
        "product_no": "006",
        "approval_date": "Aug 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "007",
        "approval_date": "Jan 17, 2024"
      }
    ],
    "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": "ANDA202827",
  "marketing_category": "ANDA",
  "nonproprietary_name": "lisdexamfetamine dimesylate",
  "start_marketing_date": "20230825",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code N06BA.

Access this data programmatically

Query Lisdexamfetamine Dimesylate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs