<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
43353-279-94
</NDCCode>
<PackageDescription>
360 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-94)
</PackageDescription>
<NDC11Code>
43353-0279-94
</NDC11Code>
<ProductNDC>
43353-279
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Valproic Acid
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Valproic Acid
</NonProprietaryName>
<DosageFormName>
CAPSULE, LIQUID FILLED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20160715
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA073484
</ApplicationNumber>
<LabelerName>
Aphena Pharma Solutions - Tennessee, LLC
</LabelerName>
<SubstanceName>
VALPROIC ACID
</SubstanceName>
<StrengthNumber>
250
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2017-10-26
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20170307
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>