<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
61990-0611-2
</NDCCode>
<PackageDescription>
10 VIAL, SINGLE-DOSE in 1 CARTON (61990-0611-2) / 10 mL in 1 VIAL, SINGLE-DOSE (61990-0611-0)
</PackageDescription>
<NDC11Code>
61990-0611-02
</NDC11Code>
<ProductNDC>
61990-0611
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Tranexamic Acid
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Tranexamic Acid
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20190930
</StartMarketingDate>
<EndMarketingDate>
20240331
</EndMarketingDate>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA212676
</ApplicationNumber>
<LabelerName>
Apollo Pharmaceuticals Inc.
</LabelerName>
<SubstanceName>
TRANEXAMIC ACID
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2024-04-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20190930
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20240331
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>