<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0113-9004-22
</NDCCode>
<PackageDescription>
15 BLISTER PACK in 1 CARTON (0113-9004-22) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
00113-9004-22
</NDC11Code>
<ProductNDC>
0113-9004
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Allergy D
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Loratadine, Pseudoephedrine Sulfate
</NonProprietaryName>
<DosageFormName>
TABLET, EXTENDED RELEASE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20251003
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA075989
</ApplicationNumber>
<LabelerName>
L. Perrigo Company
</LabelerName>
<SubstanceName>
LORATADINE; PSEUDOEPHEDRINE SULFATE
</SubstanceName>
<StrengthNumber>
10; 240
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-10-07
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251003
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>