Trulicity

Product NDC: 0002-1433
11-digit product format: 000021433
Labeler code: 0002
Product ID: 0002-1433_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: 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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

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	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

boxed warning

WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), and Nonclinical Toxicology ( 13.1 )] . TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of TRULICITY and inform them of symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with TRULICITY [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. Dulaglutide causes thyroid C-cell tumors in rats. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ).

Warnings cross-check#

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warnings and cautions

5 WARNINGS AND PRECAUTIONS Thyroid C-cell Tumors: See Boxed Warning ( 5.1 ). Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including TRULICITY. Discontinue if pancreatitis is suspected ( 5.2 ). Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin secretagogue or insulin may be necessary ( 5.3 ). Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) have occurred. Discontinue TRULICITY and promptly seek medical advice ( 5.4 ). Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion ( 5.5 ). Severe Gastrointestinal Adverse Reactions: Use may be associated with gastrointestinal adverse reactions, sometimes severe. TRULICITY is not recommended in patients with severe gastroparesis ( 5.6 ). Diabetic Retinopathy Complications: Have been reported in a cardiovascular outcomes trial. Monitor patients with a history of diabetic retinopathy ( 5.7 ). Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated ( 5.8 ). Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures ( 5.9 ). 5.1 Risk of Thyroid C-cell Tumors In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure [see Nonclinical Toxicology ( 13.1 )] . Glucagon-like peptide-1 (GLP-1) receptor agonists have induced thyroid C-cell adenomas and carcinomas in mice and rats at clinically relevant exposures. It is unknown whether TRULICITY will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. One case of MTC was reported in a patient treated with TRULICITY in a clinical trial. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN). An additional case of C...

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS The following serious reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.5 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.6 )] Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy [see Warnings and Precautions ( 5.7 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.8 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence ≥5%) are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse Reactions in the Clinical Trials in Adults with Type 2 Diabetes Mellitus Pool of Adult Placebo-Controlled Trials for TRULICITY 0.75 mg and 1.5 mg Doses The data in Table 1 are derived from a pool of placebo-controlled trials and include 1,670 adult patients with type 2 diabetes mellitus exposed to TRULICITY with a mean duration of exposure of 23.8 weeks [see Clinical Studies ( 14 )] . The mean age of patients was 56 years, 1% were 75 years or older and 53% were male. The population was 69% White, 7% Black or African American, 13% Asian; 30% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8 years, a mean HbA1c of 8.0%, and 2.5% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60 mL/min/1.73 m 2 ) in 96%. Table 1 shows adverse reactions, excluding hypoglycemia, occurring in ≥5% of TRULICITY treated adult patients an...

adverse reactions table

Table 1: Adverse Reactions in Pool of Placebo-Controlled Trials That Occurred in ≥5% of TRULICITY-Treated Adult Patients with Type 2 Diabetes Mellitus a Includes diarrhea, fecal volume increased, frequent bowel movements. b Includes retching, vomiting, vomiting projectile. c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, gastrointestinal pain. d Includes fatigue, asthenia, malaise. Note: Percentages reflect the number of patients that reported at least 1 treatment-emergent occurrence of the adverse reaction. Adverse ReactionPlacebo (N=568) %TRULICITY 0.75 mg (N=836) %TRULICITY 1.5 mg (N=834) %Nausea 5.3 12.4 21.1 Diarrheaa6.7 8.9 12.6 Vomitingb2.3 6.0 12.7 Abdominal Painc4.9 6.5 9.4 Decreased Appetite 1.6 4.9 8.6 Dyspepsia 2.3 4.1 5.8 Fatigued2.6 4.2 5.6

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 Identifiers#

Field, Values table
Field	Values
Unii	WTT295HSY5
Rxcui	1551295, 1551300, 1551304, 1551306, 2395777, 2395779, 2395783, 2395785

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

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	2026-06-01

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	2026-03-12	HUMAN PRESCRIPTION DRUG LABEL	60
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

Trulicity

openFDA label cross-check#

Boxed warning cross-check#

boxed warning

Warnings cross-check#

warnings and cautions

Adverse reactions cross-check#

adverse reactions

adverse reactions table

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Purple Book Biologic Products#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#