<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
58809-200-60
</NDCCode>
<PackageDescription>
60 CAPSULE in 1 BOTTLE (58809-200-60)
</PackageDescription>
<NDC11Code>
58809-0200-60
</NDC11Code>
<ProductNDC>
58809-200
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Folene
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Prescription Folate Preparation
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20160810
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED DRUG OTHER
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
GM Pharmaceuticals, Inc.
</LabelerName>
<SubstanceName>
LEVOMEFOLIC ACID; ACETYLCYSTEINE MAGNESIUM; CALCIUM CITRATE; CHOLECALCIFEROL; MAGNESIUM CITRATE
</SubstanceName>
<StrengthNumber>
2; 100; 200; 3775; 500
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1; mg/1; [iU]/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2017-03-07
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>