<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
51662-1457-3
</NDCCode>
<PackageDescription>
10 POUCH in 1 CASE (51662-1457-3) / 1 VIAL, PATENT DELIVERY SYSTEM in 1 POUCH (51662-1457-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM
</PackageDescription>
<NDC11Code>
51662-1457-03
</NDC11Code>
<ProductNDC>
51662-1457
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Diltiazem Hci
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Diltiazem Hci
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20191215
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA075853
</ApplicationNumber>
<LabelerName>
HF Acquisition Co LLC, DBA HealthFirst
</LabelerName>
<SubstanceName>
DILTIAZEM HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-03-12
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20221211
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>