<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet type="text/xsl" href="https://www.accessdata.fda.gov/spl/stylesheet/spl.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="50dd0707-c3cb-47a4-8d71-4f4760ffe5f8"/>
   <code code="81203-2" displayName="BULK INGREDIENT - ANIMAL DRUG" codeSystem="2.16.840.1.113883.6.1"/>
   <title>Xylazine Hcl</title>
   <effectiveTime value="20220418"/>
   <setId root="acef72e9-0baf-4a93-8c5f-e4f5096e4079"/>
   <versionNumber value="17"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="079891426" root="1.3.6.1.4.1.519.1"/>
            <name>LETCO MEDICAL, LLC</name>
            <assignedEntity>
               <assignedOrganization/>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="b59791bc-418e-4571-bb6d-1aa16f76e6e1"/>
               <code code="48780-1" displayName="SPL listing data elements section" codeSystem="2.16.840.1.113883.6.1"/>
               <effectiveTime value="20250502"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="62991-1624" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Xylazine hydrochloride</name>
                        <formCode code="C42972" displayName="POWDER" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>xylazine hydrochloride</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIM">
                           <quantity>
                              <numerator unit="g" value="1"/>
                              <denominator unit="g" value="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="NGC3S0882S" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>XYLAZINE HYDROCHLORIDE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="2KFG9TP5V8" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>XYLAZINE</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator unit="g" value="25"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="62991-1624-2" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43195" displayName="JAR" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator unit="g" value="100"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="62991-1624-3" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43195" displayName="JAR" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator unit="g" value="1000"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="62991-1624-4" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43195" displayName="JAR" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           </containerPackagedProduct>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <code code="C98252" displayName="BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <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="completed"/>
                           <effectiveTime>
                              <low value="20111209"/>
                              <high value="20281011"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C48623" displayName="NOT APPLICABLE" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section ID="LINK_084002bf-d475-47c4-a923-88d210f61561">
               <id root="1720abe9-68c5-4db0-920c-07b5ba1bb094"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title/>
               <text>
                  <renderMultiMedia referencedObject="MM1">
                     <caption>Xylazine Hydrochloride USP 100gm</caption>
                  </renderMultiMedia>
               </text>
               <effectiveTime value="20220418"/>
               <component>
                  <observationMedia ID="MM1">
                     <text>Xylazine Hydrochloride USP</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="xylazine-hcl-1.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>