NDC 0115-1565

Teriflunomide

Teriflunomide

Teriflunomide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Teriflunomide.

Product ID0115-1565_ed5b2e8a-3ef9-44c2-ba77-b75abbd811e6
NDC0115-1565
Product TypeHuman Prescription Drug
Proprietary NameTeriflunomide
Generic NameTeriflunomide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-06-17
Marketing CategoryANDA / ANDA
Application NumberANDA209677
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameTERIFLUNOMIDE
Active Ingredient Strength14 mg/1
Pharm ClassesPyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0115-1565-44

28 TABLET, FILM COATED in 1 CARTON (0115-1565-44)
Marketing Start Date2020-06-17
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0115-1565TeriflunomideTeriflunomide
68462-311teriflunomideteriflunomide
68462-312teriflunomideteriflunomide
69238-1303TeriflunomideTeriflunomide
69238-1304TeriflunomideTeriflunomide
69539-032TeriflunomideTeriflunomide
69539-033TeriflunomideTeriflunomide
58468-0210Aubagioteriflunomide
58468-0211Aubagioteriflunomide

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