<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
81279-135-10
</NDCCode>
<PackageDescription>
10 BOTTLE in 1 CARTON (81279-135-10) / 10 mg in 1 BOTTLE
</PackageDescription>
<NDC11Code>
81279-0135-10
</NDC11Code>
<ProductNDC>
81279-135
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Sdamlo
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Amlodipine
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20251229
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA219531
</ApplicationNumber>
<LabelerName>
Pangea Pharmaceuticals, LLC
</LabelerName>
<SubstanceName>
AMLODIPINE BESYLATE
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
mg/10mg
</StrengthUnit>
<Pharm_Classes>
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-05
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251229
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>