Label: LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 27, 2016

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    LEVONORGESTREL AND ETHINYL ESTRADIOL  
    levonorgestrel and ethinyl estradiol kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57994-008
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57994-008-902 in 1 CARTON01/01/2017
    11 in 1 POUCH
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1 84 
    Part 2
    Part 1 of 2
    LEVONORGESTREL AND ETHINYL ESTRADIOL  
    levonorgestrel and ethinyl estradiol tablet
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL0.1 mg
    ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U) ETHINYL ESTRADIOL0.02 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 214
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20049301/01/2017
    Part 2 of 2
    ETHINYL ESTRADIOL  
    ethinyl estradiol tablet
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U) ETHINYL ESTRADIOL0.01 mg
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
    POVIDONE K25 (UNII: K0KQV10C35)  
    Product Characteristics
    ColorORANGE (Light Peach) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 215
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20049301/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20049301/01/2017
    Labeler - Jai Pharma Limited (650882132)
    Registrant - Jai Pharma Limited (650882132)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jai Pharma Limited677604150analysis(57994-008) , label(57994-008) , manufacture(57994-008) , pack(57994-008)