FDA.reportPublic FDA data

TRULICITY

Product NDC
50090-6571
Requested package NDC
50090-6571-0
11-digit product format
500906571
Labeler code
50090
Product ID
50090-6571_acaa63ae-a7bc-4997-9bfb-6292ff7bed52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dulaglutide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA125469
Marketing category
BLA
Marketing start
2020-09-03
Substance
DULAGLUTIDE
Active strength
3 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
2026-12-31
Current FDA listing
Yes

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULAGLUTIDE3 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WTT295HSY5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2395777Internal RxNorm lookup
2395779Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a4716d0-9c9c-4bc3-a8f1-6784599aae89Available on FDA.report

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
50090-6571-0TRULICITY4 in 1 CARTONINJECTION, SOLUTION411
50090-6571-0TRULICITY.5 mL in 1 SYRINGEINJECTION, SOLUTION.511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6571-0ML - Milliliter50090-65717045104d-c947-455d-be28-34fd7773118712023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6571TRULICITY (DULAGLUTIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]11Current NDC, 2 package rows20230806_0a4716d0-9c9c-4bc3-a8f1-6784599aae89.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrulicityDULAGLUTIDEEli Lilly and Company463050bd-2b1c-40f5-b3c3-0a04bb4333092026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125469
TRULICITYDULAGLUTIDEA-S Medication Solutionsaf4e38a6-ad3f-480c-ae82-5ac6c7735b992025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125469
TrulicityDULAGLUTIDEA-S Medication Solutions58353438-3236-4596-9324-62fed9615cb72023-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125469
TrulicityDULAGLUTIDEA-S Medication Solutions6088c732-afa1-4fee-9206-22e52baf47312023-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125469
TRULICITYDULAGLUTIDEA-S Medication Solutions0a4716d0-9c9c-4bc3-a8f1-6784599aae892023-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125469
ndc (package): 50090-6571-0
ndc (product): 50090-6571
ndc11 (package): 50090657100
TRULICITYDULAGLUTIDEA-S Medication Solutionsa923e467-fea3-431c-b7e4-c9669af607b72023-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125469
TRULICITYDULAGLUTIDEA-S Medication Solutions80d1e766-fefc-44b4-bec9-c7b0198ec08f2023-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125469

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125469Trulicitydulaglutide351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2395777dulaglutide 3 MG in 0.5 ML Auto-InjectorPSN0a4716d0-9c9c-4bc3-a8f1-6784599aae8911
2395779Trulicity 3 MG in 0.5 ML Auto-InjectorPSN0a4716d0-9c9c-4bc3-a8f1-6784599aae8911
23957790.5 ML dulaglutide 6 MG/ML Auto-Injector [Trulicity]SBD0a4716d0-9c9c-4bc3-a8f1-6784599aae8911
23957770.5 ML dulaglutide 6 MG/ML Auto-InjectorSCD0a4716d0-9c9c-4bc3-a8f1-6784599aae8911
23957790.5 ML Trulicity 6 MG/ML Auto-InjectorSY0a4716d0-9c9c-4bc3-a8f1-6784599aae8911
2395777dulaglutide 3 MG per 0.5 ML Auto-InjectorSY0a4716d0-9c9c-4bc3-a8f1-6784599aae8911
2395779Trulicity 3 MG per 0.5 ML Auto-InjectorSY0a4716d0-9c9c-4bc3-a8f1-6784599aae8911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6571-0500906571004 SYRINGE in 1 CARTON (50090-6571-0) / .5 mL in 1 SYRINGE4 syringe2023-08-01NoNoCurrent