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United States · US · US:31722-321_37397df5-ba32-4489-a34b-81a61f5b860d

LISDEXAMFETAMINE DIMESYLATE

In shortageOrange BookUNIISPLATC N06BA

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN06BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3172232101
    100 TABLET, CHEWABLE in 1 BOTTLE (31722-321-01)

Annotations

UNII (FDA Substance ID)
SJT761GEGS
LISDEXAMFETAMINE DIMESYLATE
RxCUI 673579
Orange Book
A217068
ABABABABABAB
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": "31722-321_37397df5-ba32-4489-a34b-81a61f5b860d",
  "productndc": "31722-321",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "217068",
    "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"
      }
    ],
    "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": "ANDA217068",
  "marketing_category": "ANDA",
  "nonproprietary_name": "lisdexamfetamine dimesylate",
  "start_marketing_date": "20230825",
  "active_numerator_strength": "10"
}

Related drugs

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