FDA.reportPublic FDA data

EBGLYSS

Product NDC
0002-7797
11-digit product format
000027797
Labeler code
0002
Product ID
0002-7797_60dc1045-5354-4f61-bf71-26129c6b07f4
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

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 · 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 (product): 0002-7797

Additional Listing Data#

Finished product
Yes
Brand name base
EBGLYSS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEBRIKIZUMAB250 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U9JLP7V031Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2693784Internal RxNorm lookup
2693791Internal RxNorm lookup
2693903Internal RxNorm lookup
2693907Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5fAvailable on FDA.report

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761306Ebglysslebrikizumab-lbkz351(a)Rx2026-06-01

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
0002-7797-01000027797012 mL in 1 SYRINGE2 mlHistorical
0002-7797-11000027797111 SYRINGE in 1 CARTON (0002-7797-11) / 2 mL in 1 SYRINGE (0002-7797-01) 1 syringe2024-09-13NoNoCurrent
0002-7797-61000027797611 SYRINGE in 1 CARTON (0002-7797-61) / 2 mL in 1 SYRINGE1 syringe2024-09-13YesNoCurrent