<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82497-020-04
</NDCCode>
<PackageDescription>
4 SYRINGE in 1 CARTON (82497-020-04) / .4 mL in 1 SYRINGE (82497-020-02)
</PackageDescription>
<NDC11Code>
82497-0020-04
</NDC11Code>
<ProductNDC>
82497-020
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Otrexup
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Methotrexate
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20240925
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA204824
</ApplicationNumber>
<LabelerName>
Assertio Specialty Pharmaceuticals, LLC
</LabelerName>
<SubstanceName>
METHOTREXATE
</SubstanceName>
<StrengthNumber>
20
</StrengthNumber>
<StrengthUnit>
mg/.4mL
</StrengthUnit>
<Pharm_Classes>
Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2026-01-08
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240925
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>