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United States · US · US:0078-0607_7b0c88c7-0bb4-44a4-9855-3156bfc63a66

Gilenya

Orange BookUNIISPLATC L04AE01

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL04AE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0078060715
    30 CAPSULE in 1 BOTTLE (0078-0607-15)

Annotations

UNII (FDA Substance ID)
G926EC510T
FINGOLIMOD HYDROCHLORIDE
RxCUI 1012891
Orange Book
N022527
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "G926EC510T",
    "rxcui": "1012891",
    "inchikey": "SWZTYAVBMYWFGS-UHFFFAOYSA-N",
    "display_name": "FINGOLIMOD HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "cc9e1c8c-0e2b-44e2-878b-27057f786be9": {
      "match": "brand_token",
      "title": "GILENYA (FINGOLIMOD HCL) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "39",
      "published_date": "2025-09-05"
    }
  },
  "productid": "0078-0607_7b0c88c7-0bb4-44a4-9855-3156bfc63a66",
  "productndc": "0078-0607",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "022527",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Sep 21, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.25MG BASE",
        "product_no": "002",
        "approval_date": "May 11, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FINGOLIMOD HYDROCHLORIDE",
  "proprietary_name": "Gilenya",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022527",
  "marketing_category": "NDA",
  "nonproprietary_name": "Fingolimod hcl",
  "start_marketing_date": "20100921",
  "active_numerator_strength": ".5"
}

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