Label: PHYTONADIONE tablet

  • NDC Code(s): 70771-1318-1, 70771-1318-2, 70771-1318-3, 70771-1318-4
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 1, 2021

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Phytonadione Tablets USP, 5 mg

    100 tablets

    NDC 70771-1318-1

    Rx only

    label
  • INGREDIENTS AND APPEARANCE
    PHYTONADIONE 
    phytonadione tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1318
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857) PHYTONADIONE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorYELLOW (LIGHT YELLOW TO YELLOW) Score2 pieces
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 1014
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1318-11 in 1 CARTON02/22/2019
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:70771-1318-410 in 1 CARTON02/22/2019
    2NDC:70771-1318-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:70771-1318-330 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21018902/22/2019
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (863362789)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1318) , MANUFACTURE(70771-1318)