<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
67414-700-01
</NDCCode>
<PackageDescription>
1 POUCH in 1 CARTON (67414-700-01) / 50 TABLET in 1 POUCH
</PackageDescription>
<NDC11Code>
67414-0700-01
</NDC11Code>
<ProductNDC>
67414-700
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Pepcid Complete Dual Action Berry Flavor
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Famotidine, Calcium Carbonate, Magnesium Hydroxide
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260730
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA020958
</ApplicationNumber>
<LabelerName>
Jones Healthcare Group - Packaging Services, Inc
</LabelerName>
<SubstanceName>
FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE
</SubstanceName>
<StrengthNumber>
10; 800; 165
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-09-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260730
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>