<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0002-3433-11
</NDCCode>
<PackageDescription>
1 SYRINGE in 1 CARTON (0002-3433-11) / 2.4 mL in 1 SYRINGE (0002-3433-01)
</PackageDescription>
<NDC11Code>
00002-3433-11
</NDC11Code>
<ProductNDC>
0002-3433
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Mounjaro
</ProprietaryName>
<ProprietaryNameSuffix>
Kwikpen
</ProprietaryNameSuffix>
<NonProprietaryName>
Tirzepatide
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20260120
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA215866
</ApplicationNumber>
<LabelerName>
Eli Lilly and Company
</LabelerName>
<SubstanceName>
TIRZEPATIDE
</SubstanceName>
<StrengthNumber>
16.7
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-02-10
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260120
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>