<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
42254-013-15
</NDCCode>
<PackageDescription>
1 BOTTLE, DROPPER in 1 CARTON (42254-013-15) > 15 mL in 1 BOTTLE, DROPPER
</PackageDescription>
<NDC11Code>
42254-0013-15
</NDC11Code>
<ProductNDC>
42254-013
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Cyclopentolate Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Cyclopentolate Hydrochloride
</NonProprietaryName>
<DosageFormName>
SOLUTION/ DROPS
</DosageFormName>
<RouteName>
OPHTHALMIC
</RouteName>
<StartMarketingDate>
19940429
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA040075
</ApplicationNumber>
<LabelerName>
Rebel Distributors Corp
</LabelerName>
<SubstanceName>
CYCLOPENTOLATE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2019-09-21
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag>
E
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20171231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>