Label: TAFLUPROST solution

  • NDC Code(s): 65302-062-05
  • Packager: The Ritedose Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 21, 2022

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  • SPL UNCLASSIFIED SECTION

    NDC 0781-6184-87

    Tafluprost Ophthalmic Solution 0.0015%

    Single-Use Containers

    Preservative-Free, Sterile

    For Topical Application in the Eye

    REFRIGERATE (2° to 8°C or 36° to 46°F)

    Rx Only

    30 Single-Use Containers:

    6 Pouches x 5 Single-Use Containers

    (0.3 mL each)

    Sandoz A Novartis Division

  • Tafluprost Ophthalmic Solution, 0.0015% Carton

    tafluprost-30ct-carton

  • INGREDIENTS AND APPEARANCE
    TAFLUPROST 
    tafluprost solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65302-062
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TAFLUPROST (UNII: 1O6WQ6T7G3) (TAFLUPROST - UNII:1O6WQ6T7G3) TAFLUPROST0.0045 mg  in 0.3 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65302-062-056 in 1 CARTON12/05/2022
    15 in 1 POUCH
    10.3 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20904012/05/2022
    Labeler - The Ritedose Corporation (837769546)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Ritedose Corporation837769546analysis(65302-062) , label(65302-062) , manufacture(65302-062) , pack(65302-062)
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