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United States · US · US:70709-065_eb717a3b-e703-4637-83c7-fccdecbac199

TASCENSO ODT

Orange BookUNIISPLATC L04AE

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

Identification

ManufacturerCycle Pharmaceuticals Ltd
CountryUS (United States)
ATC codeL04AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7070906530
    3 BLISTER PACK in 1 CARTON (70709-065-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
J3HZQ9BE2S
FINGOLIMOD LAURYL SULFATE
RxCUI 2610292
Orange Book
N214962
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "J3HZQ9BE2S",
    "rxcui": "2610292",
    "inchikey": "XTLZVNMZICNQBB-UHFFFAOYSA-N",
    "display_name": "FINGOLIMOD LAURYL SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "bf8e7f89-ea09-43c7-a7eb-e44724350721": {
      "match": "brand_token",
      "title": "TASCENSO ODT (FINGOLIMOD LAURYL SULFATE) TABLET, ORALLY DISINTEGRATING [CYCLE PHARMACEUTICALS LTD]",
      "spl_version": "8",
      "published_date": "2026-03-12"
    }
  },
  "productid": "70709-065_eb717a3b-e703-4637-83c7-fccdecbac199",
  "productndc": "70709-065",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "214962",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.25MG BASE",
        "product_no": "001",
        "approval_date": "Dec 23, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.5MG BASE",
        "product_no": "002",
        "approval_date": "Dec 9, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FINGOLIMOD LAURYL SULFATE",
  "proprietary_name": "TASCENSO ODT",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214962",
  "marketing_category": "NDA",
  "nonproprietary_name": "Fingolimod Lauryl Sulfate",
  "start_marketing_date": "20230201",
  "active_numerator_strength": ".5"
}

Related drugs

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