FDA.reportPublic FDA data

EBGLYSS

Product NDC
0002-7797
Requested package NDC
0002-7797-61
11-digit product format
000027797
Labeler code
0002
Product ID
0002-7797_190124d7-2239-400c-8580-ffb0358c1d6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lebrikizumab-lbkz
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA761306
Marketing category
BLA
Marketing start
2024-09-13
Substance
LEBRIKIZUMAB
Active strength
250 mg/2mL
Pharmacologic classes
Interleukin-13 Antagonist [EPC], Interleukin-13 Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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
EBGLYSS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEBRIKIZUMAB250 mg/2mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1c47de52-8e46-4293-b413-5ffda01be927Product name120250331
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-7797-01EBGLYSS2 mL in 1 SYRINGEINJECTION, SOLUTION212
0002-7797-11EBGLYSS1 in 1 CARTONINJECTION, SOLUTION112
0002-7797-61EBGLYSS2 mL in 1 SYRINGEINJECTION, SOLUTION212
0002-7797-61EBGLYSS1 in 1 CARTONINJECTION, SOLUTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-7797-01ML - Milliliter0002-779748041087-4104-44e0-aade-4d4ad578072912024-12-10
0002-7797-11ML - Milliliter0002-77974c887d3c-e165-404b-b3df-91214c6211c612024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-7797EBGLYSS (LEBRIKIZUMAB-LBKZ) INJECTION, SOLUTION [ELI LILLY AND COMPANY]6Current NDC, 4 package rows20250212_7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f.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
EBGLYSSLEBRIKIZUMAB-LBKZEli Lilly and Company7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f2026-06-09Warnings, Adverse reactionsExact identifier
application number: BLA761306
ndc (package): 0002-7797-61
ndc (product): 0002-7797
ndc11 (package): 00002779761

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761306Ebglysslebrikizumab-lbkz351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2693907Ebglyss 250 MG in 2 ML Pen InjectorPSN7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f12
2693791Ebglyss 250 MG in 2 ML Prefilled SyringePSN7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f12
2693903lebrikizumab-lbkz 250 MG in 2 ML Pen InjectorPSN7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f12
2693784lebrikizumab-lbkz 250 MG in 2 ML Prefilled SyringePSN7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f12
26939072 ML lebrikizumab-lbkz 125 MG/ML Pen Injector [Ebglyss]SBD7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f12
26937912 ML lebrikizumab-lbkz 125 MG/ML Prefilled Syringe [Ebglyss]SBD7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f12
26939032 ML lebrikizumab-lbkz 125 MG/ML Pen InjectorSCD7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f12
26937842 ML lebrikizumab-lbkz 125 MG/ML Prefilled SyringeSCD7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f12
26939072 ML Ebglyss 125 MG/ML Pen InjectorSY7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f12
26937912 ML Ebglyss 125 MG/ML Prefilled SyringeSY7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f12
2693907Ebglyss 250 MG per 2 ML Pen InjectorSY7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f12
2693791Ebglyss 250 MG per 2 ML Prefilled SyringeSY7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f12
2693903lebrikizumab-lbkz 250 MG per 2 ML Pen InjectorSY7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f12
2693784lebrikizumab-lbkz 250 MG per 2 ML Prefilled SyringeSY7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0002-7797-61000027797611 SYRINGE in 1 CARTON (0002-7797-61) / 2 mL in 1 SYRINGE1 syringe2024-09-13YesNoCurrent