<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
48433-030-20
</NDCCode>
<PackageDescription>
100 BLISTER PACK in 1 CARTON (48433-030-20) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (48433-030-01)
</PackageDescription>
<NDC11Code>
48433-0030-20
</NDC11Code>
<ProductNDC>
48433-030
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Diltiazem Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Diltiazem Hydrochloride
</NonProprietaryName>
<DosageFormName>
CAPSULE, EXTENDED RELEASE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260202
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA074910
</ApplicationNumber>
<LabelerName>
Safecor Health LLC
</LabelerName>
<SubstanceName>
DILTIAZEM HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
60
</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>
2026-02-05
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260202
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>