Gilenya - 0078-0607-51 - (Fingolimod hcl)

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Drug Information of Gilenya

Product NDC: 0078-0607
Proprietary Name: Gilenya
Non Proprietary Name: Fingolimod hcl
Active Ingredient(s): .5    mg/1 & nbsp;   Fingolimod hcl
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Coding System: National Drug Codes(NDC)

Labeler Information of Gilenya

Product NDC: 0078-0607
Labeler Name: Novartis Pharmaceuticals Corporation
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA022527
Marketing Category: NDA
Start Marketing Date: 20100921

Package Information of Gilenya

Package NDC: 0078-0607-51
Package Description: 28 CAPSULE in 1 CARTON (0078-0607-51)

NDC Information of Gilenya

NDC Code 0078-0607-51
Proprietary Name Gilenya
Package Description 28 CAPSULE in 1 CARTON (0078-0607-51)
Product NDC 0078-0607
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Fingolimod hcl
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 20100921
Marketing Category Name NDA
Labeler Name Novartis Pharmaceuticals Corporation
Substance Name FINGOLIMOD HYDROCHLORIDE
Strength Number .5
Strength Unit mg/1
Pharmaceutical Classes Sphingosine 1-Phosphate Receptor Modulators [MoA],Sphingosine 1-phosphate Receptor Modulator [EPC]

Complete Information of Gilenya


General Information