Trulicity

Product NDC: 0002-1433
11-digit product format: 000021433
Labeler code: 0002
Product ID: 0002-1433_cfddaea0-134c-48f2-95df-3cff565e366e
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: 2014-09-18
Substance: DULAGLUTIDE
Active strength: .75 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0002-1433	0002-1433-61	D	Discontinued by firm		2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DULAGLUTIDE	.75 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WTT295HSY5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1551295	Internal RxNorm lookup
1551300	Internal RxNorm lookup
1551304	Internal RxNorm lookup
1551306	Internal RxNorm lookup
2395777	Internal RxNorm lookup
2395779	Internal RxNorm lookup
2395783	Internal RxNorm lookup
2395785	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
463050bd-2b1c-40f5-b3c3-0a04bb433309	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
431af9bc-94ac-4e4b-abaa-84d1d87e74ac	Product name	1	20150331
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0002-1433-01	Trulicity	0.5 mL in 1 SYRINGE	INJECTION, SOLUTION	0.5	60
0002-1433-61	Trulicity	0.5 mL in 1 SYRINGE	INJECTION, SOLUTION	0.5	60
0002-1433-61	Trulicity	2 in 1 CARTON	INJECTION, SOLUTION	2	60
0002-1433-80	Trulicity	4 in 1 CARTON	INJECTION, SOLUTION	4	60

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0002-1433-01	ML - Milliliter	0002-1433	847fb266-84a3-41df-bfa0-5fa2023a8c74	1	2014-11-05
0002-1433-61	ML - Milliliter	0002-1433	e79ca535-b831-4c92-bac7-34f92b429a4a	1	2019-04-11
0002-1433-80	ML - Milliliter	0002-1433	a298abfd-15a7-4fa7-9728-b1cbb53c6a6a	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dulaglutide	ACTIVE INGREDIENT	WTT295HSY5	TRULICITY (DULAGLUTIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	13
Dulaglutide	ACTIVE MOIETY	WTT295HSY5	TRULICITY (DULAGLUTIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	13
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	TRULICITY (DULAGLUTIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	13
Mannitol	INACTIVE INGREDIENT	3OWL53L36A	TRULICITY (DULAGLUTIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	13
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	TRULICITY (DULAGLUTIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	13
Trisodium Citrate Dihydrate	INACTIVE INGREDIENT	B22547B95K	TRULICITY (DULAGLUTIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	13
Water	INACTIVE INGREDIENT	059QF0KO0R	TRULICITY (DULAGLUTIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0002-1433	TRULICITY (DULAGLUTIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	54	Current NDC, Legacy NDC, 4 package rows	20241114_463050bd-2b1c-40f5-b3c3-0a04bb433309.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trulicity	DULAGLUTIDE	Eli Lilly and Company	463050bd-2b1c-40f5-b3c3-0a04bb433309	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125469 ndc (product): 0002-1433
TRULICITY	DULAGLUTIDE	A-S Medication Solutions	af4e38a6-ad3f-480c-ae82-5ac6c7735b99	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125469
Trulicity	DULAGLUTIDE	A-S Medication Solutions	58353438-3236-4596-9324-62fed9615cb7	2023-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125469
Trulicity	DULAGLUTIDE	A-S Medication Solutions	6088c732-afa1-4fee-9206-22e52baf4731	2023-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125469
TRULICITY	DULAGLUTIDE	A-S Medication Solutions	0a4716d0-9c9c-4bc3-a8f1-6784599aae89	2023-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125469
TRULICITY	DULAGLUTIDE	A-S Medication Solutions	a923e467-fea3-431c-b7e4-c9669af607b7	2023-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125469
TRULICITY	DULAGLUTIDE	A-S Medication Solutions	80d1e766-fefc-44b4-bec9-c7b0198ec08f	2023-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125469

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125469	Trulicity	dulaglutide	351(a)	Rx	2026-09-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WTT295HSY5	DULAGLUTIDE	923950-08-7	DULAGLUTIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1551295	dulaglutide 0.75 MG in 0.5 ML Auto-Injector	PSN	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
1551304	dulaglutide 1.5 MG in 0.5 ML Auto-Injector	PSN	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
2395777	dulaglutide 3 MG in 0.5 ML Auto-Injector	PSN	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
2395783	dulaglutide 4.5 MG in 0.5 ML Auto-Injector	PSN	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
1551300	Trulicity 0.75 MG in 0.5 ML Auto-Injector	PSN	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
1551306	Trulicity 1.5 MG in 0.5 ML Auto-Injector	PSN	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
2395779	Trulicity 3 MG in 0.5 ML Auto-Injector	PSN	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
2395785	Trulicity 4.5 MG in 0.5 ML Auto-Injector	PSN	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
1551300	0.5 ML dulaglutide 1.5 MG/ML Auto-Injector [Trulicity]	SBD	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
1551306	0.5 ML dulaglutide 3 MG/ML Auto-Injector [Trulicity]	SBD	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
2395779	0.5 ML dulaglutide 6 MG/ML Auto-Injector [Trulicity]	SBD	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
2395785	0.5 ML dulaglutide 9 MG/ML Auto-Injector [Trulicity]	SBD	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
1551295	0.5 ML dulaglutide 1.5 MG/ML Auto-Injector	SCD	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
1551304	0.5 ML dulaglutide 3 MG/ML Auto-Injector	SCD	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
2395777	0.5 ML dulaglutide 6 MG/ML Auto-Injector	SCD	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
2395783	0.5 ML dulaglutide 9 MG/ML Auto-Injector	SCD	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
1551300	0.5 ML Trulicity 1.5 MG/ML Auto-Injector	SY	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
1551306	0.5 ML Trulicity 3 MG/ML Auto-Injector	SY	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
2395779	0.5 ML Trulicity 6 MG/ML Auto-Injector	SY	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
2395785	0.5 ML Trulicity 9 MG/ML Auto-Injector	SY	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
1551295	dulaglutide 0.75 MG per 0.5 ML Auto-Injector	SY	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
1551304	dulaglutide 1.5 MG per 0.5 ML Auto-Injector	SY	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
2395777	dulaglutide 3 MG per 0.5 ML Auto-Injector	SY	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
2395783	dulaglutide 4.5 MG per 0.5 ML Auto-Injector	SY	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
1551300	Trulicity 0.75 MG per 0.5 ML Auto-Injector	SY	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
1551306	Trulicity 1.5 MG per 0.5 ML Auto-Injector	SY	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
2395779	Trulicity 3 MG per 0.5 ML Auto-Injector	SY	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
2395785	Trulicity 4.5 MG per 0.5 ML Auto-Injector	SY	463050bd-2b1c-40f5-b3c3-0a04bb433309	60
1551295	dulaglutide 0.75 MG in 0.5 ML Auto-Injector	PSN	58353438-3236-4596-9324-62fed9615cb7	12
1551304	dulaglutide 1.5 MG in 0.5 ML Auto-Injector	PSN	58353438-3236-4596-9324-62fed9615cb7	12
1551300	Trulicity 0.75 MG in 0.5 ML Auto-Injector	PSN	58353438-3236-4596-9324-62fed9615cb7	12
1551306	Trulicity 1.5 MG in 0.5 ML Auto-Injector	PSN	58353438-3236-4596-9324-62fed9615cb7	12
1551300	0.5 ML dulaglutide 1.5 MG/ML Auto-Injector [Trulicity]	SBD	58353438-3236-4596-9324-62fed9615cb7	12
1551306	0.5 ML dulaglutide 3 MG/ML Auto-Injector [Trulicity]	SBD	58353438-3236-4596-9324-62fed9615cb7	12
1551295	0.5 ML dulaglutide 1.5 MG/ML Auto-Injector	SCD	58353438-3236-4596-9324-62fed9615cb7	12
1551304	0.5 ML dulaglutide 3 MG/ML Auto-Injector	SCD	58353438-3236-4596-9324-62fed9615cb7	12
1551300	0.5 ML Trulicity 1.5 MG/ML Auto-Injector	SY	58353438-3236-4596-9324-62fed9615cb7	12
1551306	0.5 ML Trulicity 3 MG/ML Auto-Injector	SY	58353438-3236-4596-9324-62fed9615cb7	12
1551295	dulaglutide 0.75 MG per 0.5 ML Auto-Injector	SY	58353438-3236-4596-9324-62fed9615cb7	12
1551304	dulaglutide 1.5 MG per 0.5 ML Auto-Injector	SY	58353438-3236-4596-9324-62fed9615cb7	12
1551300	Trulicity 0.75 MG per 0.5 ML Auto-Injector	SY	58353438-3236-4596-9324-62fed9615cb7	12
1551306	Trulicity 1.5 MG per 0.5 ML Auto-Injector	SY	58353438-3236-4596-9324-62fed9615cb7	12
1551295	dulaglutide 0.75 MG in 0.5 ML Auto-Injector	PSN	a923e467-fea3-431c-b7e4-c9669af607b7	1
1551300	Trulicity 0.75 MG in 0.5 ML Auto-Injector	PSN	a923e467-fea3-431c-b7e4-c9669af607b7	1
1551300	0.5 ML dulaglutide 1.5 MG/ML Auto-Injector [Trulicity]	SBD	a923e467-fea3-431c-b7e4-c9669af607b7	1
1551295	0.5 ML dulaglutide 1.5 MG/ML Auto-Injector	SCD	a923e467-fea3-431c-b7e4-c9669af607b7	1
1551300	0.5 ML Trulicity 1.5 MG/ML Auto-Injector	SY	a923e467-fea3-431c-b7e4-c9669af607b7	1
1551295	dulaglutide 0.75 MG per 0.5 ML Auto-Injector	SY	a923e467-fea3-431c-b7e4-c9669af607b7	1
1551300	Trulicity 0.75 MG per 0.5 ML Auto-Injector	SY	a923e467-fea3-431c-b7e4-c9669af607b7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0002-1433-01	00002143301	0.5 mL in 1 SYRINGE	0.5 ml					Historical
0002-1433-61	00002143361	2 SYRINGE in 1 CARTON (0002-1433-61) > .5 mL in 1 SYRINGE	2 syringe	2014-11-07	0000-00-00	Yes	No	Current
0002-1433-80	00002143380	4 SYRINGE in 1 CARTON (0002-1433-80) / .5 mL in 1 SYRINGE (0002-1433-01)	4 syringe	2014-11-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trulicity	Eli Lilly and Company	2026-06-16	HUMAN PRESCRIPTION DRUG LABEL	62
Trulicity	A-S Medication Solutions	2023-12-12	HUMAN PRESCRIPTION DRUG LABEL	12
TRULICITY	A-S Medication Solutions	2023-05-03	HUMAN PRESCRIPTION DRUG LABEL	1