Lisdexamfetamine Dimesylate

In shortageOrange BookUNIISPLATC N06BA

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

Identification

ManufacturerElite Laboratories, Inc.

CountryUS (United States)

ATC codeN06BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6485055301
100 CAPSULE in 1 BOTTLE (64850-553-01)

Annotations

UNII (FDA Substance ID)

SJT761GEGS

LISDEXAMFETAMINE DIMESYLATE

RxCUI 673579

Orange Book

A218604

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": "64850-553_81cfbfd5-71c0-4c39-bcf3-2eae9fbd48fa",
  "productndc": "64850-553",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "218604",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Nov 15, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Nov 15, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Nov 15, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "004",
        "approval_date": "Nov 15, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "005",
        "approval_date": "Nov 15, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "006",
        "approval_date": "Nov 15, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "70MG",
        "product_no": "007",
        "approval_date": "Nov 15, 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": "ANDA218604",
  "marketing_category": "ANDA",
  "nonproprietary_name": "lisdexamfetamine dimesylate",
  "start_marketing_date": "20241115",
  "active_numerator_strength": "40"
}

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