FDA.reportPublic FDA data

Adbry

Product NDC
50222-350
11-digit product format
502220350
Labeler code
50222
Product ID
50222-350_8abedac8-f75e-42a0-8591-10fabcf41fb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tralokinumab-ldrm
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
LEO Pharma Inc.
Application
BLA761180
Marketing category
BLA
Marketing start
2024-07-01
Substance
TRALOKINUMAB
Active strength
300 mg/2mL
Pharmacologic classes
Interleukin-13 Antagonist [EPC], Interleukin-13 Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRALOKINUMAB300 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GK1LYB375AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2589378Internal RxNorm lookup
2589384Internal RxNorm lookup
2686061Internal RxNorm lookup
2686065Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d8020b69-3001-44e2-9b5d-5f93d9aaf6e1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
712e8f33-9f56-4223-a82f-094cfeadb487Product name120220921
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50222-350-00Adbry2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION215
50222-350-01Adbry1 in 1 CARTONINJECTION, SOLUTION115
50222-350-02Adbry2 in 1 CARTONINJECTION, SOLUTION215
50222-350-90Adbry2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION215
50222-350-91Adbry1 in 1 CARTONINJECTION, SOLUTION115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50222-350-01ML - Milliliter50222-3501c95778d-13f4-4575-ab11-32f372f0ccc712024-07-12
50222-350-02ML - Milliliter50222-350441aab3e-eac6-4925-8a1e-ea00d43c205812024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50222-350ADBRY (TRALOKINUMAB-LDRM) INJECTION, SOLUTION [LEO PHARMA INC.]14Current NDC, 5 package rows20240701_d8020b69-3001-44e2-9b5d-5f93d9aaf6e1.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdbryTRALOKINUMAB-LDRMLEO Pharma Inc.d8020b69-3001-44e2-9b5d-5f93d9aaf6e12025-12-17Warnings, Adverse reactionsExact identifier
application number: BLA761180
ndc (product): 50222-350

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761180Adbrytralokinumab-ldrm351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2589384Adbry 150 MG/ML in 1 ML Prefilled SyringePSNd8020b69-3001-44e2-9b5d-5f93d9aaf6e115
2686065Adbry 300 MG in 2 ML Auto-InjectorPSNd8020b69-3001-44e2-9b5d-5f93d9aaf6e115
2589378tralokinumab-ldrm 150 MG in 1 ML Prefilled SyringePSNd8020b69-3001-44e2-9b5d-5f93d9aaf6e115
2686061tralokinumab-ldrm 300 MG in 2 ML Auto-InjectorPSNd8020b69-3001-44e2-9b5d-5f93d9aaf6e115
25893841 ML tralokinumab-ldrm 150 MG/ML Prefilled Syringe [Adbry]SBDd8020b69-3001-44e2-9b5d-5f93d9aaf6e115
26860652 ML tralokinumab-ldrm 150 MG/ML Auto-Injector [Adbry]SBDd8020b69-3001-44e2-9b5d-5f93d9aaf6e115
25893781 ML tralokinumab-ldrm 150 MG/ML Prefilled SyringeSCDd8020b69-3001-44e2-9b5d-5f93d9aaf6e115
26860612 ML tralokinumab-ldrm 150 MG/ML Auto-InjectorSCDd8020b69-3001-44e2-9b5d-5f93d9aaf6e115
2589384Adbry 150 MG per 1 ML Prefilled SyringeSYd8020b69-3001-44e2-9b5d-5f93d9aaf6e115
2589384Adbry 150 MG/ML per 1 ML Prefilled SyringeSYd8020b69-3001-44e2-9b5d-5f93d9aaf6e115
2686065Adbry 300 MG per 2 ML Auto-InjectorSYd8020b69-3001-44e2-9b5d-5f93d9aaf6e115
2589378tralokinumab-ldrm 150 MG per 1 ML Prefilled SyringeSYd8020b69-3001-44e2-9b5d-5f93d9aaf6e115
2589378tralokinumab-ldrm 150 MG/ML per 1 ML Prefilled SyringeSYd8020b69-3001-44e2-9b5d-5f93d9aaf6e115
2686061tralokinumab-ldrm 300 MG per 2 ML Auto-InjectorSYd8020b69-3001-44e2-9b5d-5f93d9aaf6e115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50222-350-00502220350002 mL in 1 SYRINGE, GLASS2 mlHistorical
50222-350-01502220350011 SYRINGE, GLASS in 1 CARTON (50222-350-01) / 2 mL in 1 SYRINGE, GLASS (50222-350-00) 2024-07-01NoNoCurrent
50222-350-02502220350022 SYRINGE, GLASS in 1 CARTON (50222-350-02) / 2 mL in 1 SYRINGE, GLASS (50222-350-00) 2024-07-01NoNoCurrent
50222-350-90502220350902 mL in 1 SYRINGE, GLASS2 mlHistorical
50222-350-91502220350911 SYRINGE, GLASS in 1 CARTON (50222-350-91) / 2 mL in 1 SYRINGE, GLASS (50222-350-90) 2024-07-01YesNoCurrent