<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68094-123-62
</NDCCode>
<PackageDescription>
3 TRAY in 1 CASE (68094-123-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-123-59)
</PackageDescription>
<NDC11Code>
68094-0123-62
</NDC11Code>
<ProductNDC>
68094-123
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Oxcarbazepine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Oxcarbazepine
</NonProprietaryName>
<DosageFormName>
SUSPENSION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20170913
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA202961
</ApplicationNumber>
<LabelerName>
Precision Dose, Inc.
</LabelerName>
<SubstanceName>
OXCARBAZEPINE
</SubstanceName>
<StrengthNumber>
300
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes>
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2023-11-22
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20170913
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>