<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
58657-860-25
</NDCCode>
<PackageDescription>
25 VIAL, SINGLE-DOSE in 1 CARTON (58657-860-25) / 5 mL in 1 VIAL, SINGLE-DOSE (58657-860-00)
</PackageDescription>
<NDC11Code>
58657-0860-25
</NDC11Code>
<ProductNDC>
58657-860
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Levetiracetam
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Levetiracetam
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20251215
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA209781
</ApplicationNumber>
<LabelerName>
Method Pharmaceuticals, LLC
</LabelerName>
<SubstanceName>
LEVETIRACETAM
</SubstanceName>
<StrengthNumber>
500
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes>
Decreased Central Nervous System Disorganized Electrical Activity [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-08
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251215
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>