FDA.reportPublic FDA data

EBGLYSS

Product NDC
0002-7772
11-digit product format
000027772
Labeler code
0002
Product ID
0002-7772_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

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 Identifiers#

Field, Values table
FieldValues
UniiU9JLP7V031
Rxcui2693784, 2693791, 2693903, 2693907

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
0002-7772-01EBGLYSS2 mL in 1 SYRINGEINJECTION, SOLUTION212
0002-7772-11EBGLYSS1 in 1 CARTONINJECTION, SOLUTION112
0002-7772-62EBGLYSS2 in 1 CARTONINJECTION, SOLUTION212
0002-7772-62EBGLYSS2 mL in 1 SYRINGEINJECTION, SOLUTION212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-7772-01ML - Milliliter0002-7772e42557cc-af8a-493c-9543-3312ed814d5e12025-12-16
0002-7772-11ML - Milliliter0002-7772cd96d2e1-f18b-41b3-8cc3-d3f7cc139d7012024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-7772EBGLYSS (LEBRIKIZUMAB-LBKZ) INJECTION, SOLUTION [ELI LILLY AND COMPANY]6Current NDC, 4 package rows20250212_7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f.zip

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
0002-7772-01000027772012 mL in 1 SYRINGE2 mlHistorical
0002-7772-11000027772111 SYRINGE in 1 CARTON (0002-7772-11) / 2 mL in 1 SYRINGE (0002-7772-01) 1 syringe2024-09-13NoNoCurrent
0002-7772-62000027772622 SYRINGE in 1 CARTON (0002-7772-62) / 2 mL in 1 SYRINGE2 syringe2024-09-13YesNoCurrent