FDA.reportPublic FDA data

Trulicity

Product NDC
0002-3182
11-digit product format
000023182
Labeler code
0002
Product ID
0002-3182_16dbc870-9954-4989-b370-78bb3520a038
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dulaglutide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA125469
Marketing category
BLA
Marketing start
2020-09-03
Substance
DULAGLUTIDE
Active strength
4.5 mg/.5mL
Pharmacologic classes
GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trulicity
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULAGLUTIDE4.5 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWTT295HSY5
Rxcui1551295, 1551300, 1551304, 1551306, 2395777, 2395779, 2395783, 2395785

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
431af9bc-94ac-4e4b-abaa-84d1d87e74acProduct name120150331
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-3182-01Trulicity0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.560
0002-3182-61Trulicity0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.560
0002-3182-61Trulicity2 in 1 CARTONINJECTION, SOLUTION260
0002-3182-80Trulicity4 in 1 CARTONINJECTION, SOLUTION460

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-3182TRULICITY (DULAGLUTIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]54Current NDC, Legacy NDC, 4 package rows20241114_463050bd-2b1c-40f5-b3c3-0a04bb433309.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1551295dulaglutide 0.75 MG in 0.5 ML Auto-InjectorPSN463050bd-2b1c-40f5-b3c3-0a04bb43330960
1551304dulaglutide 1.5 MG in 0.5 ML Auto-InjectorPSN463050bd-2b1c-40f5-b3c3-0a04bb43330960
2395777dulaglutide 3 MG in 0.5 ML Auto-InjectorPSN463050bd-2b1c-40f5-b3c3-0a04bb43330960
2395783dulaglutide 4.5 MG in 0.5 ML Auto-InjectorPSN463050bd-2b1c-40f5-b3c3-0a04bb43330960
1551300Trulicity 0.75 MG in 0.5 ML Auto-InjectorPSN463050bd-2b1c-40f5-b3c3-0a04bb43330960
1551306Trulicity 1.5 MG in 0.5 ML Auto-InjectorPSN463050bd-2b1c-40f5-b3c3-0a04bb43330960
2395779Trulicity 3 MG in 0.5 ML Auto-InjectorPSN463050bd-2b1c-40f5-b3c3-0a04bb43330960
2395785Trulicity 4.5 MG in 0.5 ML Auto-InjectorPSN463050bd-2b1c-40f5-b3c3-0a04bb43330960
15513000.5 ML dulaglutide 1.5 MG/ML Auto-Injector [Trulicity]SBD463050bd-2b1c-40f5-b3c3-0a04bb43330960
15513060.5 ML dulaglutide 3 MG/ML Auto-Injector [Trulicity]SBD463050bd-2b1c-40f5-b3c3-0a04bb43330960
23957790.5 ML dulaglutide 6 MG/ML Auto-Injector [Trulicity]SBD463050bd-2b1c-40f5-b3c3-0a04bb43330960
23957850.5 ML dulaglutide 9 MG/ML Auto-Injector [Trulicity]SBD463050bd-2b1c-40f5-b3c3-0a04bb43330960
15512950.5 ML dulaglutide 1.5 MG/ML Auto-InjectorSCD463050bd-2b1c-40f5-b3c3-0a04bb43330960
15513040.5 ML dulaglutide 3 MG/ML Auto-InjectorSCD463050bd-2b1c-40f5-b3c3-0a04bb43330960
23957770.5 ML dulaglutide 6 MG/ML Auto-InjectorSCD463050bd-2b1c-40f5-b3c3-0a04bb43330960
23957830.5 ML dulaglutide 9 MG/ML Auto-InjectorSCD463050bd-2b1c-40f5-b3c3-0a04bb43330960
15513000.5 ML Trulicity 1.5 MG/ML Auto-InjectorSY463050bd-2b1c-40f5-b3c3-0a04bb43330960
15513060.5 ML Trulicity 3 MG/ML Auto-InjectorSY463050bd-2b1c-40f5-b3c3-0a04bb43330960
23957790.5 ML Trulicity 6 MG/ML Auto-InjectorSY463050bd-2b1c-40f5-b3c3-0a04bb43330960
23957850.5 ML Trulicity 9 MG/ML Auto-InjectorSY463050bd-2b1c-40f5-b3c3-0a04bb43330960
1551295dulaglutide 0.75 MG per 0.5 ML Auto-InjectorSY463050bd-2b1c-40f5-b3c3-0a04bb43330960
1551304dulaglutide 1.5 MG per 0.5 ML Auto-InjectorSY463050bd-2b1c-40f5-b3c3-0a04bb43330960
2395777dulaglutide 3 MG per 0.5 ML Auto-InjectorSY463050bd-2b1c-40f5-b3c3-0a04bb43330960
2395783dulaglutide 4.5 MG per 0.5 ML Auto-InjectorSY463050bd-2b1c-40f5-b3c3-0a04bb43330960
1551300Trulicity 0.75 MG per 0.5 ML Auto-InjectorSY463050bd-2b1c-40f5-b3c3-0a04bb43330960
1551306Trulicity 1.5 MG per 0.5 ML Auto-InjectorSY463050bd-2b1c-40f5-b3c3-0a04bb43330960
2395779Trulicity 3 MG per 0.5 ML Auto-InjectorSY463050bd-2b1c-40f5-b3c3-0a04bb43330960
2395785Trulicity 4.5 MG per 0.5 ML Auto-InjectorSY463050bd-2b1c-40f5-b3c3-0a04bb43330960
2395783dulaglutide 4.5 MG in 0.5 ML Auto-InjectorPSNaf4e38a6-ad3f-480c-ae82-5ac6c7735b991
2395785Trulicity 4.5 MG in 0.5 ML Auto-InjectorPSNaf4e38a6-ad3f-480c-ae82-5ac6c7735b991
23957850.5 ML dulaglutide 9 MG/ML Auto-Injector [Trulicity]SBDaf4e38a6-ad3f-480c-ae82-5ac6c7735b991
23957830.5 ML dulaglutide 9 MG/ML Auto-InjectorSCDaf4e38a6-ad3f-480c-ae82-5ac6c7735b991
23957850.5 ML Trulicity 9 MG/ML Auto-InjectorSYaf4e38a6-ad3f-480c-ae82-5ac6c7735b991
2395783dulaglutide 4.5 MG per 0.5 ML Auto-InjectorSYaf4e38a6-ad3f-480c-ae82-5ac6c7735b991
2395785Trulicity 4.5 MG per 0.5 ML Auto-InjectorSYaf4e38a6-ad3f-480c-ae82-5ac6c7735b991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-3182-01000023182010.5 mL in 1 SYRINGE0.5 mlHistorical
0002-3182-61000023182612 SYRINGE in 1 CARTON (0002-3182-61) / .5 mL in 1 SYRINGE2 syringe2020-09-300000-00-00YesNoCurrent
0002-3182-80000023182804 SYRINGE in 1 CARTON (0002-3182-80) / .5 mL in 1 SYRINGE (0002-3182-01) 4 syringe2020-09-030000-00-00NoNoCurrent