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 ID | 0078-0607_242ee18e-e5e6-4ad3-a660-6691ea7c0816 |
NDC | 0078-0607 |
Product Type | Human Prescription Drug |
Proprietary Name | Gilenya |
Generic Name | Fingolimod Hcl |
Dosage Form | Capsule |
Route of Administration | ORAL |
Marketing Start Date | 2010-09-21 |
Marketing Category | NDA / NDA |
Application Number | NDA022527 |
Labeler Name | Novartis Pharmaceuticals Corporation |
Substance Name | FINGOLIMOD HYDROCHLORIDE |
Active Ingredient Strength | 1 mg/1 |
Pharm Classes | Sphingosine 1-Phosphate Receptor Modulators [MoA],Sphingosine 1-phosphate Receptor Modulator [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2010-09-21 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA022527 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2010-09-21 |
Marketing End Date | 2016-11-30 |
Marketing Category | NDA |
Application Number | NDA022527 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2010-09-21 |
Marketing Category | NDA |
Application Number | NDA022527 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2010-09-21 |
Ingredient | Strength |
---|---|
FINGOLIMOD HYDROCHLORIDE | .5 mg/1 |
SPL SET ID: | cc9e1c8c-0e2b-44e2-878b-27057f786be9 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
0078-0607 | Gilenya | Fingolimod hcl |
0078-0965 | Gilenya | Fingolimod hcl |
64980-449 | fingolimod | Fingolimod hcl |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GILENYA 85694643 4331093 Live/Registered |
Novartis AG 2012-08-03 |
GILENYA 85124824 not registered Dead/Abandoned |
Novartis AG 2010-09-08 |
GILENYA 77412497 3894262 Live/Registered |
Novartis AG 2008-03-04 |