<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
59088-795-54
</NDCCode>
<PackageDescription>
30 TABLET in 1 BOTTLE, PLASTIC (59088-795-54)
</PackageDescription>
<NDC11Code>
59088-0795-54
</NDC11Code>
<ProductNDC>
59088-795
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Folcyteine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Multivitamin
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20230914
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED DRUG OTHER
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
PureTek Corporation
</LabelerName>
<SubstanceName>
ACETYLCYSTEINE; CALCIUM CITRATE; CHOLECALCIFEROL; FOLIC ACID; MAGNESIUM CITRATE
</SubstanceName>
<StrengthNumber>
200; 47; 800; 1000; 16
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1; [iU]/1; ug/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Decreased Respiratory Secretion Viscosity [PE], Increased Coagulation Factor Activity [PE], Increased Glutathione Concentration [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], Mucolytic [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Reduction Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin D [CS], Vitamin D [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2023-09-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20230914
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>