<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
65145-158-25
</NDCCode>
<PackageDescription>
25 VIAL in 1 CARTON (65145-158-25) / 1 mL in 1 VIAL (65145-158-01)
</PackageDescription>
<NDC11Code>
65145-0158-25
</NDC11Code>
<ProductNDC>
65145-158
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Ephedrine Sulfate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ephedrine Sulfate
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20240815
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA219050
</ApplicationNumber>
<LabelerName>
Caplin Steriles Limited
</LabelerName>
<SubstanceName>
EPHEDRINE SULFATE
</SubstanceName>
<StrengthNumber>
50
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-08-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240815
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>