![FANATREX (GABAPENTIN) KIT [CALIFORNIA PHARMACEUTICALS, LLC]](https://medic.hrt.org//dailymed/images/2731faa1-a7a9-5c4d-e054-00144ff88e88/Fanatrex CS73-A1 rev 3 (API Label Gabapentin 10.5g) California Pharmaceuticals LLC.jpg)
![FANATREX (GABAPENTIN) KIT [CALIFORNIA PHARMACEUTICALS, LLC]](https://medic.hrt.org//dailymed/images/2731faa1-a7a9-5c4d-e054-00144ff88e88/Fanatrex CS74-A1 rev 3 (Label Fanatrex Flavor Suspension) California Pharmaceuticals LLC.jpg)
![FANATREX (GABAPENTIN) KIT [CALIFORNIA PHARMACEUTICALS, LLC]](https://medic.hrt.org//dailymed/images/2731faa1-a7a9-5c4d-e054-00144ff88e88/Fanatrex Principle Display Panel CS95-A1 - Label Fanatrex Kit.jpg)
![FANATREX (GABAPENTIN) KIT [CALIFORNIA PHARMACEUTICALS, LLC]](https://medic.hrt.org//dailymed/images/2731faa1-a7a9-5c4d-e054-00144ff88e88/New - Fanatrex CS75-A1 rev 3 (Insert Fanatrex Kit) California Pharmaceuticals LLC_Page_1.jpg)
![FANATREX (GABAPENTIN) KIT [CALIFORNIA PHARMACEUTICALS, LLC]](https://medic.hrt.org//dailymed/images/2731faa1-a7a9-5c4d-e054-00144ff88e88/New - Fanatrex CS75-A1 rev 3 (Insert Fanatrex Kit) California Pharmaceuticals LLC_Page_2.jpg)
| NDC | 70332-105-01 |
| Set ID | 2731faa1-a7a9-5c4d-e054-00144ff88e88 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | California Pharmaceuticals, LLC |
| Generic Name | |
| Product Class | Anti-epileptic Agent |
| Product Number | |
| Application Number |
- 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 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)
