<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85622-004-30
</NDCCode>
<PackageDescription>
30 TABLET in 1 BOTTLE (85622-004-30)
</PackageDescription>
<NDC11Code>
85622-0004-30
</NDC11Code>
<ProductNDC>
85622-004
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Folvitra
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Folic Acid, Vitamin D3
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20250911
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED DRUG OTHER
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Blue Heron Pharmaceuticals, LLC
</LabelerName>
<SubstanceName>
CHOLECALCIFEROL; FOLIC ACID
</SubstanceName>
<StrengthNumber>
125; 1
</StrengthNumber>
<StrengthUnit>
ug/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Vitamin D [CS], Vitamin D [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-10-15
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251013
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>