FDA.reportPublic FDA data

Mounjaro

Product NDC
0002-3455
11-digit product format
000023455
Labeler code
0002
Product ID
0002-3455_08af2d71-07e5-474b-98a2-eb5be9bcf894
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tirzepatide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
NDA215866
Marketing category
NDA
Marketing start
2026-01-20
Substance
TIRZEPATIDE
Active strength
8.33 mg/mL
Pharmacologic 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]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mounjaro
Brand name suffix
KwikPen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIRZEPATIDE8.33 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOYN3CCI6QE
Rxcui2601743, 2601746, 2601755, 2601758, 2601761, 2601764, 2601767, 2601770, 2601773, 2601776, 2601784, 2601785, 2644396, 2644399, 2644401, 2644403, 2644405, 2644407, 2644409, 2644411

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
764832a6-c731-479b-b340-b4c8813a2a29Product name120250724
079c774f-6797-40bd-b11b-fd311f893a4eProduct name120230124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-3455-01Mounjaro KwikPen2.4 mL in 1 SYRINGEINJECTION, SOLUTION2.438
0002-3455-11Mounjaro KwikPen1 in 1 CARTONINJECTION, SOLUTION138

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2601770mounjaro 10 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644419mounjaro 10 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2735292mounjaro 10 MG per dose (40 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601776mounjaro 12.5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644415mounjaro 12.5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2735294mounjaro 12.5 MG per dose (50 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733666mounjaro 12.5 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601758mounjaro 15 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644411mounjaro 15 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2735297mounjaro 15 MG per dose (60 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733668mounjaro 16.7 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601764mounjaro 2.5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644407mounjaro 2.5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2735286mounjaro 2.5 MG per dose (10 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733670mounjaro 20.8 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733671mounjaro 25 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733673mounjaro 4.17 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601746mounjaro 5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644403mounjaro 5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2735288mounjaro 5 MG per dose (20 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601785mounjaro 7.5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644399mounjaro 7.5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2735290mounjaro 7.5 MG per dose (30 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733675mounjaro 8.33 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601767tirzepatide 10 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644417tirzepatide 10 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2734628tirzepatide 10 MG per dose (40 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601773tirzepatide 12.5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644413tirzepatide 12.5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2734632tirzepatide 12.5 MG per dose (50 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2732437tirzepatide 12.5 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601755tirzepatide 15 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644409tirzepatide 15 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2734636tirzepatide 15 MG per dose (60 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2732442tirzepatide 16.7 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601761tirzepatide 2.5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644405tirzepatide 2.5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2734640tirzepatide 2.5 MG per dose (10 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2732446tirzepatide 20.8 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2732449tirzepatide 25 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2732452tirzepatide 4.17 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601743tirzepatide 5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644401tirzepatide 5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2734644tirzepatide 5 MG per dose (20 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2601784tirzepatide 7.5 MG in 0.5 ML Auto-InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2644396tirzepatide 7.5 MG in 0.5 ML InjectionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2734623tirzepatide 7.5 MG per dose (30 MG in 2.4 ML) Pen InjectorPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2732456tirzepatide 8.33 MG/ML Injectable SolutionPSNd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017460.5 ML tirzepatide 10 MG/ML Auto-Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444030.5 ML tirzepatide 10 MG/ML Injection [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017850.5 ML tirzepatide 15 MG/ML Auto-Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26443990.5 ML tirzepatide 15 MG/ML Injection [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017700.5 ML tirzepatide 20 MG/ML Auto-Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444190.5 ML tirzepatide 20 MG/ML Injection [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017760.5 ML tirzepatide 25 MG/ML Auto-Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444150.5 ML tirzepatide 25 MG/ML Injection [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017580.5 ML tirzepatide 30 MG/ML Auto-Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444110.5 ML tirzepatide 30 MG/ML Injection [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017640.5 ML tirzepatide 5 MG/ML Auto-Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444070.5 ML tirzepatide 5 MG/ML Injection [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
27352902.4 ML tirzepatide 12.5 MG/ML Pen Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
27352922.4 ML tirzepatide 16.7 MG/ML Pen Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
27352942.4 ML tirzepatide 20.8 MG/ML Pen Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
27352972.4 ML tirzepatide 25 MG/ML Pen Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
27352862.4 ML tirzepatide 4.17 MG/ML Pen Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
27352882.4 ML tirzepatide 8.33 MG/ML Pen Injector [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733666tirzepatide 12.5 MG/ML Injectable Solution [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733668tirzepatide 16.7 MG/ML Injectable Solution [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733670tirzepatide 20.8 MG/ML Injectable Solution [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733671tirzepatide 25 MG/ML Injectable Solution [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733673tirzepatide 4.17 MG/ML Injectable Solution [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
2733675tirzepatide 8.33 MG/ML Injectable Solution [Mounjaro]SBDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017430.5 ML tirzepatide 10 MG/ML Auto-InjectorSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444010.5 ML tirzepatide 10 MG/ML InjectionSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017840.5 ML tirzepatide 15 MG/ML Auto-InjectorSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26443960.5 ML tirzepatide 15 MG/ML InjectionSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017670.5 ML tirzepatide 20 MG/ML Auto-InjectorSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444170.5 ML tirzepatide 20 MG/ML InjectionSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26017730.5 ML tirzepatide 25 MG/ML Auto-InjectorSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038
26444130.5 ML tirzepatide 25 MG/ML InjectionSCDd2d7da5d-ad07-4228-955f-cf7e355c8cc038

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0002-3455-01000023455012.4 mL in 1 SYRINGE2.4 mlHistorical
0002-3455-11000023455111 SYRINGE in 1 CARTON (0002-3455-11) / 2.4 mL in 1 SYRINGE (0002-3455-01) 1 syringe2026-01-20NoNoCurrent