<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
45802-491-84
</NDCCode>
<PackageDescription>
4 BOTTLE, UNIT-DOSE in 1 CARTON (45802-491-84) / 1 SPRAY in 1 BOTTLE, UNIT-DOSE
</PackageDescription>
<NDC11Code>
45802-0491-84
</NDC11Code>
<ProductNDC>
45802-491
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Cyanocobalamin
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Cyanocobalamin
</NonProprietaryName>
<DosageFormName>
SPRAY
</DosageFormName>
<RouteName>
NASAL
</RouteName>
<StartMarketingDate>
20231228
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA212458
</ApplicationNumber>
<LabelerName>
Padagis Israel Pharmaceuticals Ltd
</LabelerName>
<SubstanceName>
CYANOCOBALAMIN
</SubstanceName>
<StrengthNumber>
500
</StrengthNumber>
<StrengthUnit>
ug/1
</StrengthUnit>
<Pharm_Classes>
Vitamin B 12 [CS], Vitamin B12 [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-01-09
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20231228
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>