<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
69751-100-12
</NDCCode>
<PackageDescription>
12 APPLICATOR in 1 BOX (69751-100-12) / 5 g in 1 APPLICATOR (69751-100-01)
</PackageDescription>
<NDC11Code>
69751-0100-12
</NDC11Code>
<ProductNDC>
69751-100
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Phexxi
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Lactic Acid, L-, Citric Acid Monohydrate, And Potassium Bitartrate
</NonProprietaryName>
<DosageFormName>
GEL
</DosageFormName>
<RouteName>
VAGINAL
</RouteName>
<StartMarketingDate>
20200801
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA208352
</ApplicationNumber>
<LabelerName>
Evofem, Inc.
</LabelerName>
<SubstanceName>
CITRIC ACID MONOHYDRATE; LACTIC ACID, L-; POTASSIUM BITARTRATE
</SubstanceName>
<StrengthNumber>
50; 90; 20
</StrengthNumber>
<StrengthUnit>
mg/5g; mg/5g; mg/5g
</StrengthUnit>
<Pharm_Classes>
Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2023-11-22
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20200901
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>