Package 58468-0210-4

Brand: aubagio

Generic: teriflunomide
NDC Package

Package Facts

Identity

Package NDC 58468-0210-4
Digits Only 5846802104
Product NDC 58468-0210
Description

1 BOTTLE in 1 CARTON (58468-0210-4) / 30 TABLET, FILM COATED in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2019-03-28
Brand aubagio
Generic teriflunomide
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "fafc0928-a014-4dfc-8f46-e0d8aa6690bc", "openfda": {"nui": ["N0000185502", "N0000185501"], "unii": ["1C058IKG3B"], "rxcui": ["1310525", "1310531", "1310533", "1310535"], "spl_set_id": ["4650d12c-b9c8-4525-b07f-a2d773eca155"], "pharm_class_epc": ["Pyrimidine Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58468-0210-1)  / 5 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "58468-0210-1", "marketing_start_date": "20130501"}, {"sample": true, "description": "1 BLISTER PACK in 1 CARTON (58468-0210-3)  / 5 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "58468-0210-3", "marketing_start_date": "20130501"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58468-0210-4)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58468-0210-4", "marketing_start_date": "20190328"}], "brand_name": "Aubagio", "product_id": "58468-0210_fafc0928-a014-4dfc-8f46-e0d8aa6690bc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]", "Pyrimidine Synthesis Inhibitor [EPC]"], "product_ndc": "58468-0210", "generic_name": "teriflunomide", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aubagio", "active_ingredients": [{"name": "TERIFLUNOMIDE", "strength": "14 mg/1"}], "application_number": "NDA202992", "marketing_category": "NDA", "marketing_start_date": "20130501", "listing_expiration_date": "20271231"}