<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0480-3493-16
</NDCCode>
<PackageDescription>
6 POUCH in 1 CARTON (0480-3493-16) / 1 BLISTER PACK in 1 POUCH (0480-3493-24) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (0480-5793-11) * 7 TABLET in 1 BLISTER PACK (0480-5794-22)
</PackageDescription>
<NDC11Code>
00480-3493-16
</NDC11Code>
<ProductNDC>
0480-3493
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Cryselle
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Norgestrel And Ethinyl Estradiol
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20251212
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA075840
</ApplicationNumber>
<LabelerName>
Teva Pharmaceuticals, Inc.
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-17
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251212
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>