<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70700-331-24
</NDCCode>
<PackageDescription>
5 TRAY in 1 CARTON (70700-331-24) / 5 AMPULE in 1 TRAY (70700-331-25) / 1 mL in 1 AMPULE
</PackageDescription>
<NDC11Code>
70700-0331-24
</NDC11Code>
<ProductNDC>
70700-331
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Phytonadione
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Phytonadione
</NonProprietaryName>
<DosageFormName>
INJECTION, EMULSION
</DosageFormName>
<RouteName>
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20250828
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA217386
</ApplicationNumber>
<LabelerName>
Xiromed LLC
</LabelerName>
<SubstanceName>
PHYTONADIONE
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-08-28
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250828
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>