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United States · US · US:59417-117_81d087b6-4cb4-466a-9693-679edeb062e2

Vyvanse

In shortageOrange BookUNIISPLATC N06BA

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

Identification

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

Packs · 1

  • ndc11
    5941711701
    100 TABLET, CHEWABLE in 1 BOTTLE (59417-117-01)

Annotations

UNII (FDA Substance ID)
SJT761GEGS
LISDEXAMFETAMINE DIMESYLATE
RxCUI 673579
Orange Book
N208510
ABABABABABAB
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": {
    "704e4378-ca83-445c-8b45-3cfa51c1ecad": {
      "match": "brand_token",
      "title": "VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPSULE VYVANSE (LISDEXAMFETAMINE DIMESYLATE) TABLET, CHEWABLE [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "81",
      "published_date": "2026-05-06"
    }
  },
  "productid": "59417-117_81d087b6-4cb4-466a-9693-679edeb062e2",
  "productndc": "59417-117",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "208510",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jan 28, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Jan 28, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Jan 28, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "004",
        "approval_date": "Jan 28, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "005",
        "approval_date": "Jan 28, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "006",
        "approval_date": "Jan 28, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LISDEXAMFETAMINE DIMESYLATE",
  "shortage_reason": "Lisdexamfetamine Dimesylate Tablet, Chewable",
  "shortage_status": "current",
  "proprietary_name": "Vyvanse",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208510",
  "marketing_category": "NDA",
  "nonproprietary_name": "LISDEXAMFETAMINE DIMESYLATE",
  "start_marketing_date": "20170128",
  "active_numerator_strength": "30"
}

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