<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68055-004-20
</NDCCode>
<PackageDescription>
840 PACKAGE in 1 CASE (68055-004-20) / 20 AMPULE in 1 PACKAGE / 20 mL in 1 AMPULE
</PackageDescription>
<NDC11Code>
68055-0004-20
</NDC11Code>
<ProductNDC>
68055-004
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Baclofen
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20221219
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Sintetica S.A.
</LabelerName>
<SubstanceName>
BACLOFEN
</SubstanceName>
<StrengthNumber>
40
</StrengthNumber>
<StrengthUnit>
mg/20mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2026-01-06
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
19-DEC-22
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>