<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0121-4027-94
</NDCCode>
<PackageDescription>
3 TRAY in 1 CASE (0121-4027-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4027-05)
</PackageDescription>
<NDC11Code>
00121-4027-94
</NDC11Code>
<ProductNDC>
0121-4027
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Lithium
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Lithium
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260414
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA070755
</ApplicationNumber>
<LabelerName>
PAI Holdings, LLC dba PAI Pharma
</LabelerName>
<SubstanceName>
LITHIUM CITRATE
</SubstanceName>
<StrengthNumber>
8
</StrengthNumber>
<StrengthUnit>
meq/5mL
</StrengthUnit>
<Pharm_Classes>
Mood Stabilizer [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-04-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260414
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>