NDC 69539-032

Teriflunomide

Teriflunomide

Teriflunomide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Msn Laboratories Private Limited. The primary component is Teriflunomide.

Product ID69539-032_3d2eaa09-9ce4-4494-b9a5-71689809b20b
NDC69539-032
Product TypeHuman Prescription Drug
Proprietary NameTeriflunomide
Generic NameTeriflunomide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-24
Marketing CategoryANDA / ANDA
Application NumberANDA209623
Labeler NameMSN LABORATORIES PRIVATE LIMITED
Substance NameTERIFLUNOMIDE
Active Ingredient Strength7 mg/1
Pharm ClassesPyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 69539-032-41

2 BLISTER PACK in 1 CARTON (69539-032-41) > 14 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2019-04-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69539-032-41 [69539003241]

Teriflunomide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209623
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-24

Drug Details

Active Ingredients

IngredientStrength
TERIFLUNOMIDE7 mg/1

Pharmacological Class

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

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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