<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
43598-182-05
</NDCCode>
<PackageDescription>
5 BAG in 1 CARTON (43598-182-05) / 250 mL in 1 BAG (43598-182-50)
</PackageDescription>
<NDC11Code>
43598-0182-05
</NDC11Code>
<ProductNDC>
43598-182
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Phenylephrine Hydrochloride Injection, Solution
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Phenylephrine Hydrochloride Injection, Solution
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20250701
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA216830
</ApplicationNumber>
<LabelerName>
Dr. Reddy's Laboratories Inc.
</LabelerName>
<SubstanceName>
PHENYLEPHRINE
</SubstanceName>
<StrengthNumber>
80
</StrengthNumber>
<StrengthUnit>
ug/mL
</StrengthUnit>
<Pharm_Classes>
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-24
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250701
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>