FDA.reportPublic FDA data

TRULICITY

Product NDC
50090-7589
Requested package NDC
50090-7589-0
11-digit product format
500907589
Labeler code
50090
Product ID
50090-7589_9815ea44-e862-451f-bcf3-cc2865ff7232
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
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
2026-12-31
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. Every label matching the complete exact-identifier union is deduplicated and paginated 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-b3c3-0a04bb4333092026-03-12Boxed 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
ndc (package): 50090-7589-0
ndc (product): 50090-7589
ndc11 (package): 50090758900
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
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

Additional Listing Data#

Finished product
Yes
Brand name base
TRULICITY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DULAGLUTIDE4.5 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
2395783Internal RxNorm lookup
2395785Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
af4e38a6-ad3f-480c-ae82-5ac6c7735b99Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
431af9bc-94ac-4e4b-abaa-84d1d87e74acProduct name120150331

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7589-0TRULICITY.5 mL in 1 SYRINGEINJECTION, SOLUTION.51
50090-7589-0TRULICITY4 in 1 CARTONINJECTION, SOLUTION41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7589-0ML - Milliliter50090-7589747e2b79-fe0c-4e59-8ca0-c3a7bd3292cc12025-08-11

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125469Trulicitydulaglutide351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
50090-7589-0500907589004 SYRINGE in 1 CARTON (50090-7589-0) / .5 mL in 1 SYRINGE4 syringe2025-07-01NoNoCurrent