<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
54473-411-01
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 BOX (54473-411-01) / 50 TABLET, COATED in 1 BOTTLE (54473-411-50)
</PackageDescription>
<NDC11Code>
54473-0411-01
</NDC11Code>
<ProductNDC>
54473-411
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Calmicid Ac
</ProprietaryName>
<ProprietaryNameSuffix>
Acid Reducer
</ProprietaryNameSuffix>
<NonProprietaryName>
Famotidine
</NonProprietaryName>
<DosageFormName>
TABLET, COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20110120
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M001
</ApplicationNumber>
<LabelerName>
Melaleuca, Inc.
</LabelerName>
<SubstanceName>
FAMOTIDINE
</SubstanceName>
<StrengthNumber>
20
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-06-05
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20180120
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>