<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
69097-503-27
</NDCCode>
<PackageDescription>
8 VIAL in 1 KIT (69097-503-27) / 1 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
69097-0503-27
</NDC11Code>
<ProductNDC>
69097-503
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Dihydroergotamine Mesylate Nasal
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Dihydroergotamine Mesylate Nasal
</NonProprietaryName>
<DosageFormName>
SPRAY, METERED
</DosageFormName>
<RouteName>
NASAL
</RouteName>
<StartMarketingDate>
20200523
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA212907
</ApplicationNumber>
<LabelerName>
Cipla USA Inc.
</LabelerName>
<SubstanceName>
DIHYDROERGOTAMINE MESYLATE
</SubstanceName>
<StrengthNumber>
4
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Ergotamine Derivative [EPC], Ergotamines [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-03
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20200523
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>