TRULICITY

Product NDC
50090-6453
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

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 Identifiers#

Field, Values table
FieldValues
UniiWTT295HSY5
Rxcui1551295, 1551300

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

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 syringe2023-04-27NoNoHistorical