gilenya

Generic: fingolimod hcl

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gilenya
Generic Name fingolimod hcl
Labeler novartis pharmaceuticals corporation
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fingolimod hydrochloride .25 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0965
Product ID 0078-0965_7b0c88c7-0bb4-44a4-9855-3156bfc63a66
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022527
Listing Expiration 2026-12-31
Marketing Start 2010-09-21

Pharmacologic Class

Classes
sphingosine 1-phosphate receptor modulators [moa] sphingosine 1-phosphate receptor modulator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780965
Hyphenated Format 0078-0965

Supplemental Identifiers

RxCUI
1012895 1012899 2045491 2045493
UNII
G926EC510T

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name gilenya (source: ndc)
Generic Name fingolimod hcl (source: ndc)
Application Number NDA022527 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/1
source: ndc
Packaging
  • 7 CAPSULE in 1 CARTON (0078-0965-89)
source: ndc

Packages (1)

0078-0965-89 7 CAPSULE in 1 CARTON (0078-0965-89)

Ingredients (1)

fingolimod hydrochloride (.25 mg/1)

Linked Drug Pages (1)

Gilenya ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7b0c88c7-0bb4-44a4-9855-3156bfc63a66", "openfda": {"unii": ["G926EC510T"], "rxcui": ["1012895", "1012899", "2045491", "2045493"], "spl_set_id": ["cc9e1c8c-0e2b-44e2-878b-27057f786be9"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "7 CAPSULE in 1 CARTON (0078-0965-89)", "package_ndc": "0078-0965-89", "marketing_start_date": "20180511"}], "brand_name": "Gilenya", "product_id": "0078-0965_7b0c88c7-0bb4-44a4-9855-3156bfc63a66", "dosage_form": "CAPSULE", "pharm_class": ["Sphingosine 1-Phosphate Receptor Modulators [MoA]", "Sphingosine 1-phosphate Receptor Modulator [EPC]"], "product_ndc": "0078-0965", "generic_name": "Fingolimod hcl", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gilenya", "active_ingredients": [{"name": "FINGOLIMOD HYDROCHLORIDE", "strength": ".25 mg/1"}], "application_number": "NDA022527", "marketing_category": "NDA", "marketing_start_date": "20100921", "listing_expiration_date": "20261231"}