<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
65219-021-01
</NDCCode>
<PackageDescription>
25 VIAL, SINGLE-DOSE in 1 TRAY (65219-021-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-021-00)
</PackageDescription>
<NDC11Code>
65219-0021-01
</NDC11Code>
<ProductNDC>
65219-021
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Oxytocin
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Oxytocin
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR; INTRAVENOUS
</RouteName>
<StartMarketingDate>
20240506
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA018248
</ApplicationNumber>
<LabelerName>
Fresenius Kabi USA, LLC
</LabelerName>
<SubstanceName>
OXYTOCIN
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
[USP'U]/mL
</StrengthUnit>
<Pharm_Classes>
Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-04-10
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240506
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>