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NDC 00078-0965-89 Gilenya 0.25 mg/1 Details
Gilenya 0.25 mg/1
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.
MedlinePlus Drug Summary
Fingolimod is used to prevent episodes of symptoms and slow the worsening of disability in adults and children 10 years of age and older with relapsing-remitting forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Fingolimod is in a class of medications called sphingosine l-phosphate receptor modulators. It works by decreasing the action of immune cells that may cause nerve damage.
Related Packages: 00078-0965-89Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fingolimod
Product Information
| NDC | 00078-0965 |
|---|---|
| Product ID | 0078-0965_ca55becd-c1e3-439a-8563-d6a60b7806e9 |
| Associated GPIs | 62407025100110 |
| GCN Sequence Number | 078464 |
| GCN Sequence Number Description | fingolimod HCl CAPSULE 0.25 MG ORAL |
| HIC3 | H0E |
| HIC3 Description | AGENTS TO TREAT MULTIPLE SCLEROSIS |
| GCN | 44798 |
| HICL Sequence Number | 037180 |
| HICL Sequence Number Description | FINGOLIMOD HCL |
| Brand/Generic | Brand |
| Proprietary Name | Gilenya |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fingolimod hcl |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 0.25 |
| Active Ingredient Units | mg/1 |
| Substance Name | FINGOLIMOD HYDROCHLORIDE |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Pharmaceutical Class | Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022527 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00078-0965-89 (00078096589)
| NDC Package Code | 0078-0965-89 |
|---|---|
| Billing NDC | 00078096589 |
| Package | 7 CAPSULE in 1 CARTON (0078-0965-89) |
| Marketing Start Date | 2018-05-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |