Label: VYNDAQEL- tafamidis meglumine capsule

  • NDC Code(s): 0069-8729-55
  • Packager: Pfizer Labs Division of Pfizer Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated January 13, 2016

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack Carton

    Vyndaqel® 20 mg

    tafamidis meglumina

    Pfizer

    PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack Carton
  • PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack

    Vyndaqel® 20 mg

    tafamidis meglumina
    Pfizer

    PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack
  • INGREDIENTS AND APPEARANCE
    VYNDAQEL 
    tafamidis meglumine capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0069-8729
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TAFAMIDIS MEGLUMINE (UNII: ZU7CF08A1A) (TAFAMIDIS - UNII:8FG9H9D31J) TAFAMIDIS MEGLUMINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize10mm
    FlavorImprint Code VYN20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0069-8729-551 in 1 CARTON12/15/2015
    130 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EXPORT ONLY12/15/2015
    Labeler - Pfizer Labs Division of Pfizer Inc. (134489525)
    Establishment
    NameAddressID/FEIBusiness Operations
    DELMAR CHEMICALS INC245906755API MANUFACTURE(0069-8729)
    Establishment
    NameAddressID/FEIBusiness Operations
    Catalent Pharma Solutions, LLC051762268ANALYSIS(0069-8729) , MANUFACTURE(0069-8729)
    Establishment
    NameAddressID/FEIBusiness Operations
    AndersonBrecon Inc.053217022LABEL(0069-8729) , PACK(0069-8729)
    Establishment
    NameAddressID/FEIBusiness Operations
    Catalent Micron Technologies, Inc.015966157PARTICLE SIZE REDUCTION(0069-8729)