Package 0078-0965-89

Brand: gilenya

Generic: fingolimod hcl
NDC Package

Package Facts

Identity

Package NDC 0078-0965-89
Digits Only 0078096589
Product NDC 0078-0965
Description

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

Marketing

Marketing Status
Marketed Since 2018-05-11
Brand gilenya
Generic fingolimod hcl
Sample Package No

Linked Drug Pages (1)

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"}