NDC 68462-311

teriflunomide

Teriflunomide

teriflunomide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., Usa. The primary component is Teriflunomide.

Product ID68462-311_547ff1b7-72fc-4820-b337-d8ee0202fefe
NDC68462-311
Product TypeHuman Prescription Drug
Proprietary Nameteriflunomide
Generic NameTeriflunomide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA209663
Labeler NameGlenmark Pharmaceuticals Inc., USA
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 68462-311-84

2 BLISTER PACK in 1 CARTON (68462-311-84) > 14 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2020-05-01
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
TERIFLUNOMIDE7 mg/1

OpenFDA Data

SPL SET ID:a07d8829-8753-476a-84fe-432c73f2c70d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1310525
  • 1310533
  • UPC Code
  • 0368462312841
  • 0368462311851
  • 0368462312858
  • Pharmacological Class

    • 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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