Label: LEVONORGESTREL AND ETHINYL ESTRADIOL - levonorgestrel and ethinyl estradiol

  • 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
  • INGREDIENTS AND APPEARANCE
    LEVONORGESTREL AND ETHINYL ESTRADIOL  
    levonorgestrel and ethinyl estradiol kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57994-008
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57994-008-90 2 in 1 CARTON 01/01/2017
    1 1 in 1 POUCH
    1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 84 
    Part 2
    Part 1 of 2
    LEVONORGESTREL AND ETHINYL ESTRADIOL  
    levonorgestrel and ethinyl estradiol tablet
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL 0.1 mg
    ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U) ETHINYL ESTRADIOL 0.02 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code 214
    Contains     
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA200493 01/01/2017
    Part 2 of 2
    ETHINYL ESTRADIOL  
    ethinyl estradiol tablet
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U) ETHINYL ESTRADIOL 0.01 mg
    Inactive Ingredients
    Ingredient Name Strength
    .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
    Color ORANGE (Light Peach) Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code 215
    Contains     
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA200493 01/01/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA200493 01/01/2017
    Labeler - Jai Pharma Limited (650882132)
    Registrant - Jai Pharma Limited (650882132)
    Establishment
    Name Address ID/FEI Business Operations
    Jai Pharma Limited 677604150 analysis(57994-008) , label(57994-008) , manufacture(57994-008) , pack(57994-008)
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