FDA.reportPublic FDA data

Zepbound

Product NDC
0002-3566
11-digit product format
000023566
Labeler code
0002
Product ID
0002-3566_86a64015-7f78-4281-8b7f-579b6c3dc1f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tirzepatide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
NDA217806
Marketing category
NDA
Marketing start
2026-01-20
Substance
TIRZEPATIDE
Active strength
4.17 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
Zepbound
Brand name suffix
KwikPen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIRZEPATIDE4.17 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOYN3CCI6QE
Rxcui2601743, 2601755, 2601761, 2601767, 2601773, 2601784, 2644396, 2644401, 2644405, 2644409, 2644413, 2644417, 2669706, 2669709, 2669712, 2669715, 2669718, 2669721, 2679317, 2679319

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
764832a6-c731-479b-b340-b4c8813a2a29Product name120250724
079c774f-6797-40bd-b11b-fd311f893a4eProduct name120230124
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-3566-01Zepbound KwikPen2.4 mL in 1 SYRINGEINJECTION, SOLUTION2.438
0002-3566-11Zepbound KwikPen1 in 1 CARTONINJECTION, SOLUTION138
0002-3566-99Zepbound KwikPen1 in 1 CARTONINJECTION, SOLUTION138
0002-3566-99Zepbound KwikPen2.4 mL in 1 SYRINGEINJECTION, SOLUTION2.438

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2601767tirzepatide 10 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644417tirzepatide 10 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734628tirzepatide 10 MG per dose (40 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2601773tirzepatide 12.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644413tirzepatide 12.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734632tirzepatide 12.5 MG per dose (50 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732437tirzepatide 12.5 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2601755tirzepatide 15 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644409tirzepatide 15 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734636tirzepatide 15 MG per dose (60 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732442tirzepatide 16.7 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2601761tirzepatide 2.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644405tirzepatide 2.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734640tirzepatide 2.5 MG per dose (10 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732446tirzepatide 20.8 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732449tirzepatide 25 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732452tirzepatide 4.17 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2601743tirzepatide 5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644401tirzepatide 5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734644tirzepatide 5 MG per dose (20 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2601784tirzepatide 7.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644396tirzepatide 7.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734623tirzepatide 7.5 MG per dose (30 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732456tirzepatide 8.33 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669715zepbound 10 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679317zepbound 10 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734630zepbound 10 MG per dose (40 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669718zepbound 12.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679319zepbound 12.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734634zepbound 12.5 MG per dose (50 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732440zepbound 12.5 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669721zepbound 15 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679321zepbound 15 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734638zepbound 15 MG per dose (60 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732444zepbound 16.7 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669706zepbound 2.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679323zepbound 2.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734642zepbound 2.5 MG per dose (10 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732448zepbound 20.8 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732450zepbound 25 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732454zepbound 4.17 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669709zepbound 5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679325zepbound 5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734646Zepbound 5 MG per dose (20 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669712zepbound 7.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679327zepbound 7.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734626zepbound 7.5 MG per dose (30 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732458zepbound 8.33 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697090.5 ML tirzepatide 10 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793250.5 ML tirzepatide 10 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697120.5 ML tirzepatide 15 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793270.5 ML tirzepatide 15 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697150.5 ML tirzepatide 20 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793170.5 ML tirzepatide 20 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697180.5 ML tirzepatide 25 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793190.5 ML tirzepatide 25 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697210.5 ML tirzepatide 30 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793210.5 ML tirzepatide 30 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697060.5 ML tirzepatide 5 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793230.5 ML tirzepatide 5 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346262.4 ML tirzepatide 12.5 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346302.4 ML tirzepatide 16.7 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346342.4 ML tirzepatide 20.8 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346382.4 ML tirzepatide 25 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346422.4 ML tirzepatide 4.17 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346462.4 ML tirzepatide 8.33 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732440tirzepatide 12.5 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732444tirzepatide 16.7 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732448tirzepatide 20.8 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732450tirzepatide 25 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732454tirzepatide 4.17 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732458tirzepatide 8.33 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26017430.5 ML tirzepatide 10 MG/ML Auto-InjectorSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26444010.5 ML tirzepatide 10 MG/ML InjectionSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26017840.5 ML tirzepatide 15 MG/ML Auto-InjectorSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26443960.5 ML tirzepatide 15 MG/ML InjectionSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26017670.5 ML tirzepatide 20 MG/ML Auto-InjectorSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26444170.5 ML tirzepatide 20 MG/ML InjectionSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26017730.5 ML tirzepatide 25 MG/ML Auto-InjectorSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26444130.5 ML tirzepatide 25 MG/ML InjectionSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0002-3566-01000023566012.4 mL in 1 SYRINGE2.4 mlHistorical
0002-3566-11000023566111 SYRINGE in 1 CARTON (0002-3566-11) / 2.4 mL in 1 SYRINGE (0002-3566-01) 1 syringe2026-01-20NoNoCurrent
0002-3566-99000023566991 SYRINGE in 1 CARTON (0002-3566-99) / 2.4 mL in 1 SYRINGE1 syringe2026-03-01YesNoCurrent