<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0310-5135-00
</NDCCode>
<PackageDescription>
12680 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM (0310-5135-00)
</PackageDescription>
<NDC11Code>
00310-5135-00
</NDC11Code>
<ProductNDC>
0310-5135
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Saxagliptin And Metformin Hydrochloride
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED, EXTENDED RELEASE
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20220615
</StartMarketingDate>
<EndMarketingDate>
20260331
</EndMarketingDate>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
AstraZeneca Pharmaceuticals LP
</LabelerName>
<SubstanceName>
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
500; 5
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-08-12
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
15-JUN-22
</StartMarketingDatePackage>
<EndMarketingDatePackage>
31-MAR-26
</EndMarketingDatePackage>
<SamplePackage/>
</NDC>