<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
43066-177-05
</NDCCode>
<PackageDescription>
5 CARTON in 1 CARTON (43066-177-05) / 1 SYRINGE, PLASTIC in 1 CARTON (43066-177-01) / 10 mL in 1 SYRINGE, PLASTIC
</PackageDescription>
<NDC11Code>
43066-0177-05
</NDC11Code>
<ProductNDC>
43066-177
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Ketamine Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ketamine Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR; INTRAVENOUS
</RouteName>
<StartMarketingDate>
20250917
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA219684
</ApplicationNumber>
<LabelerName>
Baxter Healthcare Corporation
</LabelerName>
<SubstanceName>
KETAMINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
General Anesthesia [PE], General Anesthetic [EPC]
</Pharm_Classes>
<DEASchedule>
CIII
</DEASchedule>
<Status>
Active
</Status>
<LastUpdate>
2025-09-30
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250917
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>