<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="fc8d67a9-6118-481c-a1e4-53269e18b31d"/>
   <code code="81203-2" codeSystem="2.16.840.1.113883.6.1" displayName="BULK INGREDIENT - ANIMAL DRUG"/>
   <title>SolutionsKits Gabapentin USP</title>
   <effectiveTime value="20250323"/>
   <setId root="b3746deb-0737-72f4-e053-2995a90a7d5f"/>
   <versionNumber value="4"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="831870824"/>
            <name>API Solutions</name>
            <assignedEntity>
               <assignedOrganization/>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="5780cec1-b27f-4637-a241-95b8bc6cff54"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20221207"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="46144-600" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>SolutitionKits</name>
                        <formCode code="C47916" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="KIT"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Gabapentin</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <asContent>
                           <quantity>
                              <numerator value="1" unit="1"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="46144-600-01" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43178" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOX"/>
                           </containerPackagedProduct>
                        </asContent>
                        <part>
                           <quantity>
                              <numerator value="22.5" unit="g"/>
                              <denominator value="1"/>
                           </quantity>
                           <partProduct>
                              <name>Gabapentin</name>
                              <formCode code="C42975" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="POWDER, FOR SUSPENSION"/>
                              <asEntityWithGeneric>
                                 <genericMedicine>
                                    <name>Gabapentin</name>
                                 </genericMedicine>
                              </asEntityWithGeneric>
                              <ingredient classCode="ACTIB">
                                 <quantity>
                                    <numerator unit="g" value="1"/>
                                    <denominator unit="g" value="1"/>
                                 </quantity>
                                 <ingredientSubstance>
                                    <code code="6CW7F3G59X" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>GABAPENTIN</name>
                                    <activeMoiety>
                                       <activeMoiety>
                                          <code code="6CW7F3G59X" codeSystem="2.16.840.1.113883.4.9"/>
                                          <name>GABAPENTIN</name>
                                       </activeMoiety>
                                    </activeMoiety>
                                 </ingredientSubstance>
                              </ingredient>
                              <asContent>
                                 <quantity>
                                    <numerator value="22.5" unit="g"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code/>
                                    <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </partProduct>
                           <subjectOf>
                              <approval>
                                 <code code="C98252" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING"/>
                                 <author>
                                    <territorialAuthority>
                                       <territory>
                                          <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                       </territory>
                                    </territorialAuthority>
                                 </author>
                              </approval>
                           </subjectOf>
                           <subjectOf>
                              <marketingAct>
                                 <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 <statusCode code="active"/>
                                 <effectiveTime>
                                    <low value="20201023"/>
                                 </effectiveTime>
                              </marketingAct>
                           </subjectOf>
                           <consumedIn>
                              <substanceAdministration>
                                 <routeCode code="C48623" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="NOT APPLICABLE"/>
                              </substanceAdministration>
                           </consumedIn>
                        </part>
                        <part>
                           <quantity>
                              <numerator value="440" unit="mL"/>
                              <denominator value="1"/>
                           </quantity>
                           <partProduct>
                              <name>Oral Suspension Vehicle</name>
                              <formCode code="C42953" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="LIQUID"/>
                              <asEntityWithGeneric>
                                 <genericMedicine>
                                    <name>Suspension</name>
                                 </genericMedicine>
                              </asEntityWithGeneric>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="C9H2L21V7U" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>MEDIUM-CHAIN TRIGLYCERIDES</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="3VRD35U26C" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>AMMONIUM GLYCYRRHIZATE</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="Q9L0O73W7L" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>COCONUT OIL</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="REK4960K2U" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>BUTYLATED HYDROXYANISOLE</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="XRQ165498B" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>POLYGLYCERYL-3 OLEATE</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="ETJ7Z6XBU4" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>SILICON DIOXIDE</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <asContent>
                                 <quantity>
                                    <numerator value="440" unit="mL"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code/>
                                    <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </partProduct>
                           <subjectOf>
                              <approval>
                                 <code code="C98252" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING"/>
                                 <author>
                                    <territorialAuthority>
                                       <territory>
                                          <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                       </territory>
                                    </territorialAuthority>
                                 </author>
                              </approval>
                           </subjectOf>
                           <subjectOf>
                              <marketingAct>
                                 <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 <statusCode code="active"/>
                                 <effectiveTime>
                                    <low value="20201023"/>
                                 </effectiveTime>
                              </marketingAct>
                           </subjectOf>
                           <consumedIn>
                              <substanceAdministration>
                                 <routeCode code="C48623" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="NOT APPLICABLE"/>
                              </substanceAdministration>
                           </consumedIn>
                        </part>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <code code="C98252" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="bulk ingredient for animal drug compounding"/>
                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
                           </author>
                        </approval>
                     </subjectOf>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20201023"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section ID="id_link_b375092c-2e3e-c971-e053-2995a90ad09f">
               <id root="b375417e-eb77-2a5c-e053-2a95a90aadec"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>SolutionKits™
  <sup/>Gabapentin
 </paragraph>
                  <paragraph>Gabapentin 50 mg/mL in SolutionKits™ Suspension Vehicle</paragraph>
                  <paragraph>FOR VETERINARY COMPOUNDING ONLY</paragraph>
                  <paragraph>Each kit includes:</paragraph>
                  <paragraph>1 bottle containing Gabapentin Powder equivalent to 22.5g Gabapentin for Oral Suspension</paragraph>
                  <paragraph>1 bottle containing 440 mL SolutionKits™ Suspension Vehicle provided as a suspending agent for compounding (Contains Artificial Chicken and Marshmallow Flavoring)</paragraph>
                  <paragraph>This kit contains 1 funnel</paragraph>
                  <paragraph/>
                  <paragraph>A.P.I.</paragraph>
                  <paragraph>Solutions</paragraph>
                  <paragraph>Daphne, AL USA</paragraph>
                  <paragraph>15 FL OZ (450 mL) as dispensed</paragraph>
               </text>
               <effectiveTime value="20201023"/>
            </section>
         </component>
         <component>
            <section ID="id_link_b374edcb-9c76-0903-e053-2995a90a880d">
               <id root="b374edcb-9c75-0903-e053-2995a90a880d"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Gabapentin Powder label</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="img_b374f458-e1cf-0ffe-e053-2995a90ac056"/>
                  </paragraph>
               </text>
               <effectiveTime value="20201023"/>
               <component>
                  <observationMedia ID="img_b374f458-e1cf-0ffe-e053-2995a90ac056">
                     <text>label</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Gaba Label.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="id_link_b43b032d-105d-3c8a-e053-2995a90a3759">
               <id root="b43b0cd6-ff6c-fdc9-e053-2a95a90ab5c8"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Supension label</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="img_b43af183-834b-0f64-e053-2995a90a3218"/>
                  </paragraph>
               </text>
               <effectiveTime value="20201023"/>
               <component>
                  <observationMedia ID="img_b43af183-834b-0f64-e053-2995a90a3218">
                     <text>suspension label</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Suspension Label.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="id_link_b374f8b5-188c-4164-e053-2a95a90ae360">
               <id root="b43b0cd6-ff6d-fdc9-e053-2a95a90ab5c8"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Box label</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="img_b374d7ed-511f-0b89-e053-2995a90a26ae"/>
                  </paragraph>
               </text>
               <effectiveTime value="20201023"/>
               <component>
                  <observationMedia ID="img_b374d7ed-511f-0b89-e053-2995a90a26ae">
                     <text>box label</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Gaba Box.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>