NDC 58468-0211

Aubagio

Teriflunomide

Aubagio is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Teriflunomide.

• Product ID: 58468-0211_00ccc1a2-a63c-418a-9f40-1792b505f2c8
• NDC: 58468-0211
• Product Type: Human Prescription Drug
• Proprietary Name: Aubagio
• Generic Name: Teriflunomide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-05-01
• Marketing Category: NDA / NDA
• Application Number: NDA202992
• Labeler Name: Genzyme Corporation
• Substance Name: TERIFLUNOMIDE
• Active Ingredient Strength: 7 mg/1
• Pharm Classes: Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 58468-0211-1

2 BLISTER PACK in 1 CARTON (58468-0211-1) > 14 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2013-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58468-0211-3 [58468021103]

Aubagio TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202992
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-05-01

NDC 58468-0211-1 [58468021101]

Aubagio TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202992
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-05-01

NDC 58468-0211-4 [58468021104]

Aubagio TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202992
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-28

NDC 58468-0211-2 [58468021102]

Aubagio TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202992
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-05-01

Drug Details

Pharmacological Class

• Pyrimidine Synthesis Inhibitor [EPC]
• Dihydroorotate Dehydrogenase Inhibitors [MoA]

NDC Crossover Matching brand name "Aubagio" or generic name "Teriflunomide"

NDC	Brand Name	Generic Name
58468-0210	Aubagio	teriflunomide
58468-0211	Aubagio	teriflunomide
0115-1565	Teriflunomide	Teriflunomide
68462-311	teriflunomide	teriflunomide
68462-312	teriflunomide	teriflunomide
69238-1303	Teriflunomide	Teriflunomide
69238-1304	Teriflunomide	Teriflunomide
69539-032	Teriflunomide	Teriflunomide
69539-033	Teriflunomide	Teriflunomide