<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68083-466-10
</NDCCode>
<PackageDescription>
10 AMPULE in 1 CARTON (68083-466-10) / 1 mL in 1 AMPULE
</PackageDescription>
<NDC11Code>
68083-0466-10
</NDC11Code>
<ProductNDC>
68083-466
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Dihydroergotamine Mesylate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Dihydroergotamine Mesylate
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20230818
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA215623
</ApplicationNumber>
<LabelerName>
Gland Pharma Limited
</LabelerName>
<SubstanceName>
DIHYDROERGOTAMINE MESYLATE
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Ergotamine Derivative [EPC], Ergotamines [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2023-08-24
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20230818
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>