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United States · US · US:72162-2451_903eb712-e3ac-4165-a87a-2fa231c21462

LISDEXAMFETAMINE DIMESYLATE

In shortageOrange BookUNIISPLATC N06BA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN06BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7216224511
    100 CAPSULE in 1 BOTTLE (72162-2451-1)
  • ndc11
    7216224519
    90 CAPSULE in 1 BOTTLE (72162-2451-9)

Annotations

UNII (FDA Substance ID)
SJT761GEGS
LISDEXAMFETAMINE DIMESYLATE
RxCUI 673579
Orange Book
A215330
ABABABABABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Lisdexamfetamine Dimesylate Tablet, Chewable
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": "72162-2451_903eb712-e3ac-4165-a87a-2fa231c21462",
  "productndc": "72162-2451",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "215330",
    "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 Tablet, Chewable",
  "shortage_status": "current",
  "proprietary_name": "LISDEXAMFETAMINE DIMESYLATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215330",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LISDEXAMFETAMINE DIMESYLATE",
  "start_marketing_date": "20240130",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06BA.

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