Label: FANATREX- gabapentin kit
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Contains inactivated NDC Code(s)
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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Fanatrex - Pharmacist Instructions Page 1
- Fanatrex - Pharmacist Instructions Page 2
- Gabapentin - Label
- Fanatex - Flavor Label
- Fanatrex - Package Label.Principal Display
- Fanatrex - Principal package label
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INGREDIENTS AND APPEARANCE
FANATREX
gabapentin kitProduct 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 suspensionProduct 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 liquidProduct 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)