<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
25021-009-05
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 CARTON (25021-009-05) / 5 mL in 1 BOTTLE
</PackageDescription>
<NDC11Code>
25021-0009-05
</NDC11Code>
<ProductNDC>
25021-009
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Timolol Maleate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Timolol Maleate
</NonProprietaryName>
<DosageFormName>
SOLUTION, GEL FORMING / DROPS
</DosageFormName>
<RouteName>
OPHTHALMIC
</RouteName>
<StartMarketingDate>
20260115
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA214645
</ApplicationNumber>
<LabelerName>
Sagent Pharmaceuticals
</LabelerName>
<SubstanceName>
TIMOLOL MALEATE
</SubstanceName>
<StrengthNumber>
5
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-15
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260115
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>