58468-0347-1 : NDC 2025 Code

58468-0347-1 : Fitusiran ( Qfitlia )

NDC Code : 58468-0347-1 – XML Data Format

                    
<?xml version="1.0" encoding="UTF-8"?>
<NDC>
	<NDCCode>
		58468-0347-1
	</NDCCode>
	<PackageDescription>
		1 VIAL in 1 CARTON (58468-0347-1)  / .2 mL in 1 VIAL
	</PackageDescription>
	<NDC11Code>
		58468-0347-01
	</NDC11Code>
	<ProductNDC>
		58468-0347
	</ProductNDC>
	<ProductTypeName>
		HUMAN PRESCRIPTION DRUG
	</ProductTypeName>
	<ProprietaryName>
		Qfitlia
	</ProprietaryName>
	<ProprietaryNameSuffix/>
	<NonProprietaryName>
		Fitusiran
	</NonProprietaryName>
	<DosageFormName>
		INJECTION, SOLUTION
	</DosageFormName>
	<RouteName>
		SUBCUTANEOUS
	</RouteName>
	<StartMarketingDate>
		20250328
	</StartMarketingDate>
	<EndMarketingDate/>
	<MarketingCategoryName>
		NDA
	</MarketingCategoryName>
	<ApplicationNumber>
		NDA219019
	</ApplicationNumber>
	<LabelerName>
		Genzyme Corporation
	</LabelerName>
	<SubstanceName>
		FITUSIRAN
	</SubstanceName>
	<StrengthNumber>
		20
	</StrengthNumber>
	<StrengthUnit>
		mg/.2mL
	</StrengthUnit>
	<Pharm_Classes>
		Antithrombin-directed RNA Interaction [EPC], Decreased RNA Integrity [PE], Increased RNA Degradation [PE], RNA, Small Interfering [CS], Small Interfering RNA [EPC]
	</Pharm_Classes>
	<DEASchedule/>
	<Status>
		Active
	</Status>
	<LastUpdate>
		2025-09-17
	</LastUpdate>
	<PackageNdcExcludeFlag>
		N
	</PackageNdcExcludeFlag>
	<ProductNdcExcludeFlag>
		N
	</ProductNdcExcludeFlag>
	<ListingRecordCertifiedThrough>
		20261231
	</ListingRecordCertifiedThrough>
	<StartMarketingDatePackage>
		20250328
	</StartMarketingDatePackage>
	<EndMarketingDatePackage/>
	<SamplePackage>
		N
	</SamplePackage>
</NDC>

                    
                

NDC XML XSD Schema

                    
<xs:schema attributeFormDefault="unqualified" elementFormDefault="qualified" xmlns:xs="http://www.w3.org/2001/XMLSchema">
  <xs:element name="NDC">
    <xs:complexType>
      <xs:sequence>
        <xs:element type="xs:string" name="NDCCode"/>
        <xs:element type="xs:string" name="PackageDescription"/>
        <xs:element type="xs:string" name="NDC11Code"/>
        <xs:element type="xs:string" name="ProductNDC"/>
        <xs:element type="xs:string" name="ProductTypeName"/>
        <xs:element type="xs:string" name="ProprietaryName"/>
        <xs:element type="xs:string" name="ProprietaryNameSuffix"/>
        <xs:element type="xs:string" name="NonProprietaryName"/>
        <xs:element type="xs:string" name="DosageFormName"/>
        <xs:element type="xs:string" name="RouteName"/>
        <xs:element type="xs:string" name="StartMarketingDate"/>
        <xs:element type="xs:string" name="EndMarketingDate"/>
        <xs:element type="xs:string" name="MarketingCategoryName"/>
        <xs:element type="xs:string" name="ApplicationNumber"/>
        <xs:element type="xs:string" name="LabelerName"/>
        <xs:element type="xs:string" name="SubstanceName"/>
        <xs:element type="xs:string" name="StrengthNumber"/>
        <xs:element type="xs:string" name="StrengthUnit"/>
        <xs:element type="xs:string" name="Pharm_Classes"/>
        <xs:element type="xs:string" name="DEASchedule"/>
        <xs:element type="xs:string" name="Status"/>
        <xs:element type="xs:string" name="LastUpdate"/>
        <xs:element type="xs:string" name="PackageNdcExcludeFlag"/>
        <xs:element type="xs:string" name="ProductNdcExcludeFlag"/>
        <xs:element type="xs:string" name="ListingRecordCertifiedThrough"/>
        <xs:element type="xs:string" name="StartMarketingDatePackage"/>
        <xs:element type="xs:string" name="EndMarketingDatePackage"/>
        <xs:element type="xs:string" name="SamplePackage"/>
      </xs:sequence>
    </xs:complexType>
  </xs:element>
</xs:schema>