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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
- ndc11007806071530 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"
}Related drugs
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- CZARELEPTANPharmaselect International Beteiligungs GmbH, Vídeň
- CZARELEPTANPharmaselect International Beteiligungs GmbH, Vídeň
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