<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85477-922-30
</NDCCode>
<PackageDescription>
30 TABLET in 1 BOTTLE, PLASTIC (85477-922-30)
</PackageDescription>
<NDC11Code>
85477-0922-30
</NDC11Code>
<ProductNDC>
85477-922
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Gestyra
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ascorbic Acid, Cholecalciferol, Thiamine, Pyridoxal Phosphate, Folic Acid, Methylcobalamin, Calcium Carbonate, Ferrous Gluconate, Potassium Iodide
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20251222
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED DRUG OTHER
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Oncora Pharma LLC
</LabelerName>
<SubstanceName>
ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; FERROUS GLUCONATE; FOLIC ACID; METHYLCOBALAMIN; POTASSIUM IODIDE; PYRIDOXAL PHOSPHATE ANHYDROUS; THIAMINE
</SubstanceName>
<StrengthNumber>
125; 200; 12.5; 13; 1; 1000; .15; 2.5; 1.4
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251222
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>