aubagio

Generic: teriflunomide

Labeler: genzyme corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name aubagio
Generic Name teriflunomide
Labeler genzyme corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

teriflunomide 7 mg/1

Manufacturer
Genzyme Corporation

Identifiers & Regulatory

Product NDC 58468-0211
Product ID 58468-0211_fafc0928-a014-4dfc-8f46-e0d8aa6690bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202992
Listing Expiration 2027-12-31
Marketing Start 2013-05-01

Pharmacologic Class

Established (EPC)
pyrimidine synthesis inhibitor [epc]
Mechanism of Action
dihydroorotate dehydrogenase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 584680211
Hyphenated Format 58468-0211

Supplemental Identifiers

RxCUI
1310525 1310531 1310533 1310535
UNII
1C058IKG3B
NUI
N0000185502 N0000185501

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 aubagio (source: ndc)
Generic Name teriflunomide (source: ndc)
Application Number NDA202992 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (58468-0211-2) / 5 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (58468-0211-3) / 5 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (58468-0211-4) / 30 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

58468-0211-2 1 BLISTER PACK in 1 CARTON (58468-0211-2) / 5 TABLET, FILM COATED in 1 BLISTER PACK 58468-0211-3 1 BLISTER PACK in 1 CARTON (58468-0211-3) / 5 TABLET, FILM COATED in 1 BLISTER PACK 58468-0211-4 1 BOTTLE in 1 CARTON (58468-0211-4) / 30 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

teriflunomide (7 mg/1)

Linked Drug Pages (1)

Aubagio ndc-match (0.9)

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 (58468-0211-2)  / 5 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "58468-0211-2", "marketing_start_date": "20130501"}, {"sample": true, "description": "1 BLISTER PACK in 1 CARTON (58468-0211-3)  / 5 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "58468-0211-3", "marketing_start_date": "20130501"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58468-0211-4)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58468-0211-4", "marketing_start_date": "20190328"}], "brand_name": "Aubagio", "product_id": "58468-0211_fafc0928-a014-4dfc-8f46-e0d8aa6690bc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dihydroorotate Dehydrogenase Inhibitors [MoA]", "Pyrimidine Synthesis Inhibitor [EPC]"], "product_ndc": "58468-0211", "generic_name": "teriflunomide", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aubagio", "active_ingredients": [{"name": "TERIFLUNOMIDE", "strength": "7 mg/1"}], "application_number": "NDA202992", "marketing_category": "NDA", "marketing_start_date": "20130501", "listing_expiration_date": "20271231"}