<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
65219-186-23
</NDCCode>
<PackageDescription>
10 VIAL in 1 TRAY (65219-186-23) / 5 mL in 1 VIAL (65219-186-13)
</PackageDescription>
<NDC11Code>
65219-0186-23
</NDC11Code>
<ProductNDC>
65219-186
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Ketamine Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ketamine Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR; INTRAVENOUS
</RouteName>
<StartMarketingDate>
20230710
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA215808
</ApplicationNumber>
<LabelerName>
Fresenius Kabi USA, LLC
</LabelerName>
<SubstanceName>
KETAMINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
General Anesthesia [PE], General Anesthetic [EPC]
</Pharm_Classes>
<DEASchedule>
CIII
</DEASchedule>
<Status>
Active
</Status>
<LastUpdate>
2025-10-18
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250418
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>