NDC 0078-0607

Gilenya

Fingolimod Hcl

Gilenya is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Fingolimod Hydrochloride.

Product ID0078-0607_242ee18e-e5e6-4ad3-a660-6691ea7c0816
NDC0078-0607
Product TypeHuman Prescription Drug
Proprietary NameGilenya
Generic NameFingolimod Hcl
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2010-09-21
Marketing CategoryNDA / NDA
Application NumberNDA022527
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameFINGOLIMOD HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesSphingosine 1-Phosphate Receptor Modulators [MoA],Sphingosine 1-phosphate Receptor Modulator [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0078-0607-15

30 CAPSULE in 1 BOTTLE (0078-0607-15)
Marketing Start Date2010-09-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0607-51 [00078060751]

Gilenya CAPSULE
Marketing CategoryNDA
Application NumberNDA022527
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-21
Marketing End Date2016-11-30

NDC 0078-0607-89 [00078060789]

Gilenya CAPSULE
Marketing CategoryNDA
Application NumberNDA022527
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-21

NDC 0078-0607-15 [00078060715]

Gilenya CAPSULE
Marketing CategoryNDA
Application NumberNDA022527
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-21

Drug Details

Active Ingredients

IngredientStrength
FINGOLIMOD HYDROCHLORIDE.5 mg/1

OpenFDA Data

SPL SET ID:cc9e1c8c-0e2b-44e2-878b-27057f786be9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2045491
  • 2045493
  • 1012895
  • 1012899
  • Pharmacological Class

    • Sphingosine 1-Phosphate Receptor Modulators [MoA]
    • Sphingosine 1-phosphate Receptor Modulator [EPC]

    NDC Crossover Matching brand name "Gilenya" or generic name "Fingolimod Hcl"

    NDCBrand NameGeneric Name
    0078-0607GilenyaFingolimod hcl
    0078-0965GilenyaFingolimod hcl
    64980-449fingolimodFingolimod hcl

    Trademark Results [Gilenya]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GILENYA
    GILENYA
    85694643 4331093 Live/Registered
    Novartis AG
    2012-08-03
    GILENYA
    GILENYA
    85124824 not registered Dead/Abandoned
    Novartis AG
    2010-09-08
    GILENYA
    GILENYA
    77412497 3894262 Live/Registered
    Novartis AG
    2008-03-04

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