FDA.reportPublic FDA data

LYUMJEV

Product NDC
0002-8235
11-digit product format
000028235
Labeler code
0002
Product ID
0002-8235_567d0b77-239e-4a05-9d84-8364e0e1ef7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Insulin lispro-aabc
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA761109
Marketing category
BLA
Marketing start
2020-06-15
Marketing end
2027-11-06
Substance
INSULIN LISPRO
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [Chemical/Ingredient]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LYUMJEV
Brand name suffix
Tempo Pen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN LISPRO100 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGFX7QIS1II
Rxcui2380231, 2380236, 2380248, 2380250, 2380254, 2380256, 2380259, 2380260, 2380265, 2380266, 2380267, 2380268

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d31d7280-9cbd-4e8c-ad8c-a830d9d6c4bfProduct name120260309
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a42609d2-d76b-4c21-bc65-ace5fa0da69dProduct name120210105
0c5ba5d1-c81f-5bcc-49a8-b8e264edfb14Product name320200325
4477e8cc-8057-4880-8829-dfea528a2efaProduct name220200325
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-8235-01LYUMJEVTempo Pen3 mL in 1 SYRINGEINJECTION, SOLUTION311
0002-8235-05LYUMJEVTempo Pen5 in 1 CARTONINJECTION, SOLUTION511
0002-8235-99LYUMJEVTempo Pen3 mL in 1 SYRINGEINJECTION, SOLUTION311
0002-8235-99LYUMJEVTempo Pen1 in 1 CARTONINJECTION, SOLUTION111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-8235LYUMJEV (INSULIN LISPRO-AABC) INJECTION, SOLUTION LYUMJEV KWIKPEN (INSULIN LISPRO-AABC) INJECTION, SOLUTION LYUMJEV JUNIOR KWIKPEN (INSULIN LISPRO-AABC) INJECTION, SOLUTION LYUMJEV TEMPO PEN (INSULIN LISPRO-AABC) INJECTION, SOLUTION LYUMJEV KWIKPEN (INSULIN LISPRO-AABC) INJECTION, SOLUTION [ELI LILLY AND COMPANY]10Current NDC, Legacy NDC, 4 package rows20241027_c5a056e2-b568-4ca6-9ed8-79c010942d00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2380248insulin lispro-aabc 100 UNT in 3 ML CartridgePSNc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380259insulin lispro-aabc 100 UNT/ML in 3 ML Pen InjectorPSNc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380267insulin lispro-aabc 100 UNT/ML in 3 ML Pen Injector with SensorPSNc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380265insulin lispro-aabc 100 UNT/ML in 3 ML Pen Injector, 0.5 UNT DosesPSNc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380231insulin lispro-aabc 100 UNT/ML Injectable SolutionPSNc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380254insulin lispro-aabc 200 UNT/ML in 3 ML Pen InjectorPSNc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380250LYUMJEV 100 UNT/ML in 3 ML CartridgePSNc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380260LYUMJEV 100 UNT/ML in 3 ML Pen InjectorPSNc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380266LYUMJEV 100 UNT/ML in 3 ML Pen Injector, 0.5 UNT DosesPSNc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380236LYUMJEV 100 UNT/ML Injectable SolutionPSNc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380256LYUMJEV 200 UNT/ML in 3 ML Pen InjectorPSNc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380268LYUMJEV Tempo 100 UNT/ML in 3 ML Pen InjectorPSNc5a056e2-b568-4ca6-9ed8-79c010942d0011
23802660.5 UNT Doses 3 ML insulin lispro-aabc 100 UNT/ML Pen Injector [Lyumjev]SBDc5a056e2-b568-4ca6-9ed8-79c010942d0011
23802503 ML insulin lispro-aabc 100 UNT/ML Cartridge [Lyumjev]SBDc5a056e2-b568-4ca6-9ed8-79c010942d0011
23802603 ML insulin lispro-aabc 100 UNT/ML Pen Injector [Lyumjev]SBDc5a056e2-b568-4ca6-9ed8-79c010942d0011
23802563 ML insulin lispro-aabc 200 UNT/ML Pen Injector [Lyumjev]SBDc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380236insulin lispro-aabc 100 UNT/ML Injectable Solution [Lyumjev]SBDc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380268Sensor 3 ML insulin lispro-aabc 100 UNT/ML Pen Injector [Lyumjev]SBDc5a056e2-b568-4ca6-9ed8-79c010942d0011
23802650.5 UNT Doses 3 ML insulin lispro-aabc 100 UNT/ML Pen InjectorSCDc5a056e2-b568-4ca6-9ed8-79c010942d0011
23802483 ML insulin lispro-aabc 100 UNT/ML CartridgeSCDc5a056e2-b568-4ca6-9ed8-79c010942d0011
23802593 ML insulin lispro-aabc 100 UNT/ML Pen InjectorSCDc5a056e2-b568-4ca6-9ed8-79c010942d0011
23802543 ML insulin lispro-aabc 200 UNT/ML Pen InjectorSCDc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380231insulin lispro-aabc 100 UNT/ML Injectable SolutionSCDc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380267Sensor 3 ML insulin lispro-aabc 100 UNT/ML Pen InjectorSCDc5a056e2-b568-4ca6-9ed8-79c010942d0011
23802503 ML Lyumjev 100 UNT/ML CartridgeSYc5a056e2-b568-4ca6-9ed8-79c010942d0011
23802603 ML Lyumjev 100 UNT/ML Pen InjectorSYc5a056e2-b568-4ca6-9ed8-79c010942d0011
23802563 ML Lyumjev 200 UNT/ML Pen InjectorSYc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380248insulin lispro-aabc 100 UNT per 3 ML CartridgeSYc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380259insulin lispro-aabc 100 UNT/ML per 3 ML Pen InjectorSYc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380267insulin lispro-aabc 100 UNT/ML per 3 ML Pen Injector with SensorSYc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380265insulin lispro-aabc 100 UNT/ML per 3 ML Pen Injector, 0.5 UNT DosesSYc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380254insulin lispro-aabc 200 UNT/ML per 3 ML Pen InjectorSYc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380236Lyumjev 100 UNT/ML Injectable SolutionSYc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380250Lyumjev 100 UNT/ML per 3 ML CartridgeSYc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380260LYUMJEV 100 UNT/ML per 3 ML Pen InjectorSYc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380266LYUMJEV 100 UNT/ML per 3 ML Pen Injector, 0.5 UNT DosesSYc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380256Lyumjev 200 UNT/ML per 3 ML Pen InjectorSYc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380268Lyumjev Tempo 100 UNT/ML per 3 ML Pen InjectorSYc5a056e2-b568-4ca6-9ed8-79c010942d0011
2380268Sensor 3 ML Lyumjev 100 UNT/ML Pen InjectorSYc5a056e2-b568-4ca6-9ed8-79c010942d0011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-8235-01000028235013 mL in 1 SYRINGE3 mlHistorical
0002-8235-05000028235055 SYRINGE in 1 CARTON (0002-8235-05) / 3 mL in 1 SYRINGE (0002-8235-01) 5 syringe2022-09-292027-11-06NoNoCurrent
0002-8235-99000028235991 SYRINGE in 1 CARTON (0002-8235-99) / 3 mL in 1 SYRINGE1 syringe2024-01-102027-11-06YesNoHistorical