FDA.reportPublic FDA data

TRULICITY

Product NDC
50090-6453
Requested package NDC
50090-6453-0
11-digit product format
500906453
Labeler code
50090
Product ID
50090-6453_ef6fe0e3-e633-4ae0-a41e-550140116e5a
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
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
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
DULAGLUTIDE.75 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
1551295Internal RxNorm lookup
1551300Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a923e467-fea3-431c-b7e4-c9669af607b7Available 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
50090-6453-0TRULICITY4 in 1 CARTONINJECTION, SOLUTION41
50090-6453-0TRULICITY.5 mL in 1 SYRINGEINJECTION, SOLUTION.51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6453-0ML - Milliliter50090-6453ee2059f0-b96f-44da-a600-e5dc74f698a712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6453TRULICITY (DULAGLUTIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20230504_a923e467-fea3-431c-b7e4-c9669af607b7.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
TRULICITYDULAGLUTIDEA-S Medication Solutionsa923e467-fea3-431c-b7e4-c9669af607b72023-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125469
ndc (package): 50090-6453-0
ndc (product): 50090-6453
ndc11 (package): 50090645300
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
1551295dulaglutide 0.75 MG in 0.5 ML Auto-InjectorPSNa923e467-fea3-431c-b7e4-c9669af607b71
1551300Trulicity 0.75 MG in 0.5 ML Auto-InjectorPSNa923e467-fea3-431c-b7e4-c9669af607b71
15513000.5 ML dulaglutide 1.5 MG/ML Auto-Injector [Trulicity]SBDa923e467-fea3-431c-b7e4-c9669af607b71
15512950.5 ML dulaglutide 1.5 MG/ML Auto-InjectorSCDa923e467-fea3-431c-b7e4-c9669af607b71
15513000.5 ML Trulicity 1.5 MG/ML Auto-InjectorSYa923e467-fea3-431c-b7e4-c9669af607b71
1551295dulaglutide 0.75 MG per 0.5 ML Auto-InjectorSYa923e467-fea3-431c-b7e4-c9669af607b71
1551300Trulicity 0.75 MG per 0.5 ML Auto-InjectorSYa923e467-fea3-431c-b7e4-c9669af607b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6453-0500906453004 SYRINGE in 1 CARTON (50090-6453-0) / .5 mL in 1 SYRINGE4 syringe2023-04-27NoNoCurrent