<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84639-212-04
</NDCCode>
<PackageDescription>
1 BLISTER PACK in 1 CARTON (84639-212-04) / 10 CAPSULE in 1 BLISTER PACK (84639-212-01)
</PackageDescription>
<NDC11Code>
84639-0212-04
</NDC11Code>
<ProductNDC>
84639-212
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Bronchitol
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Mannitol
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
RESPIRATORY (INHALATION)
</RouteName>
<StartMarketingDate>
20241002
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA202049
</ApplicationNumber>
<LabelerName>
Arna Pharma Pty Ltd
</LabelerName>
<SubstanceName>
MANNITOL
</SubstanceName>
<StrengthNumber>
40
</StrengthNumber>
<StrengthUnit>
mg/101
</StrengthUnit>
<Pharm_Classes>
Increased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2026-01-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20241002
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>