Label: FANATREX- gabapentin

  • NDC Code(s): 70332-105-01
  • Packager: California Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 7, 2016

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

  • Fanatrex - Pharmacist Instructions Page 1
  • Fanatrex - Pharmacist Instructions Page 2
  • Gabapentin - Label
  • Fanatex - Flavor Label
  • Fanatrex - Package Label.Principal Display
  • Fanatrex - Principal package label
  • INGREDIENTS AND APPEARANCE
    FANATREX 
    gabapentin kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70332-105
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70332-105-01 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE, GLASS 10.8 g
    Part 2 1 BOTTLE, PLASTIC 420 mL
    Part 1 of 2
    GABAPENTIN 
    gabapentin powder, for suspension
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN 10.8 g  in 10.8 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 10.5 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/01/2016
    Part 2 of 2
    ORAL SUSPENSION VEHICLE 
    suspension liquid
    Product Information
    Route of Administration ORAL
    Inactive Ingredients
    Ingredient Name Strength
    STEVIA LEAF (UNII: 6TC6NN0876)  
    WATER (UNII: 059QF0KO0R)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    BANANA (UNII: 4AJZ4765R9)  
    STRAWBERRY (UNII: 4J2TY8Y81V)  
    ALTHAEA OFFICINALIS LEAF (UNII: E2QQV92338)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/01/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/01/2016
    Labeler - California Pharmaceuticals, LLC (021420944)
    Establishment
    Name Address ID/FEI Business Operations
    California Pharmaceuticals, LLC 021420944 manufacture(70332-105)
    Close