FDA.reportPublic FDA data

Humalog

Product NDC
0002-8213
11-digit product format
000028213
Labeler code
0002
Product ID
0002-8213_d0a38a0f-9d29-44eb-bfd1-c83cbcba1008
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Insulin lispro
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA020563
Marketing category
BLA
Marketing start
2017-06-06
Marketing end
2027-04-04
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
Humalog
Brand name suffix
Tempo Pen

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii059QF0KO0R, GFX7QIS1II
Rxcui242120, 865098, 1652239, 1652242, 1652639, 1652640, 1652644, 1652646, 1926331, 1926332, 2621571, 2621572

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
a42609d2-d76b-4c21-bc65-ace5fa0da69dProduct name120210105
0c5ba5d1-c81f-5bcc-49a8-b8e264edfb14Product name320200325
4477e8cc-8057-4880-8829-dfea528a2efaProduct name220200325

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0002-8213-052024-01-30C16284748780-11030e365-4515-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HUMALOG safely and effectively. See full prescribing information for HUMALOG. HUMALOG (insulin lispro) injection, for subcutaneous or intravenous use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-8213-01Humalog Tempo Pen3 mL in 1 SYRINGEINJECTION, SOLUTION386
0002-8213-05Humalog Tempo Pen5 in 1 CARTONINJECTION, SOLUTION586

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-8213HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG JUNIOR KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG TEMPO PEN (INSULIN LISPRO) INJECTION, SOLUTION STERILE DILUENT (DILUENT) INJECTION, SOLUTION HUMALOG TEMPO PEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]84Current NDC, Legacy NDC, 2 package rows20250523_c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1652646HumaLOG 100 UNT/ML in 3 ML CartridgePSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652640HumaLOG 100 UNT/ML in 3 ML Pen InjectorPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
865098HumaLOG 100 UNT/ML Injectable SolutionPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652242HumaLOG 200 UNT/ML in 3 ML Pen InjectorPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1926332HumaLOG Junior 100 UNT/ML in 3 ML Pen InjectorPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621572HumaLOG Tempo 100 UNT/ML in 3 ML Pen InjectorPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652644insulin lispro 100 UNT/ML in 3 ML CartridgePSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652639insulin lispro 100 UNT/ML in 3 ML Pen InjectorPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621571insulin lispro 100 UNT/ML in 3 ML Pen Injector with SensorPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1926331insulin lispro 100 UNT/ML in 3 ML Pen Injector, 0.5 UNT DosesPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
242120insulin lispro 100 UNT/ML Injectable SolutionPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652239insulin lispro 200 UNT/ML in 3 ML Pen InjectorPSNc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
19263320.5 UNT Doses 3 ML insulin lispro 100 UNT/ML Pen Injector [Humalog]SBDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16526463 ML insulin lispro 100 UNT/ML Cartridge [Humalog]SBDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16526403 ML insulin lispro 100 UNT/ML Pen Injector [Humalog]SBDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16522423 ML insulin lispro 200 UNT/ML Pen Injector [Humalog]SBDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
865098insulin lispro 100 UNT/ML Injectable Solution [Humalog]SBDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621572Sensor 3 ML insulin lispro 100 UNT/ML Pen Injector [Humalog]SBDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
19263310.5 UNT Doses 3 ML insulin lispro 100 UNT/ML Pen InjectorSCDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16526443 ML insulin lispro 100 UNT/ML CartridgeSCDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16526393 ML insulin lispro 100 UNT/ML Pen InjectorSCDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16522393 ML insulin lispro 200 UNT/ML Pen InjectorSCDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
242120insulin lispro 100 UNT/ML Injectable SolutionSCDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621571Sensor 3 ML insulin lispro 100 UNT/ML Pen InjectorSCDc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
19263320.5 UNT Doses 3 ML Humalog 100 UNT/ML Pen InjectorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16526463 ML Humalog 100 UNT/ML CartridgeSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16526403 ML Humalog 100 UNT/ML Pen InjectorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
16522423 ML Humalog 200 UNT/ML Pen InjectorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
865098Humalog 100 UNT/ML Injectable SolutionSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652646Humalog 100 UNT/ML per 3 ML CartridgeSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621572Humalog 100 UNT/ML per 3 ML Pen Injector with SensorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621572Humalog 300 UNT per 3 ML Pen Injector with SensorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652242Humalog 600 UNT per 3 ML KwikPenSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1926332Humalog Junior KwikPen 100 UNT/ML per 3 ML Pen InjectorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652640Humalog KwikPen 100 UNT/ML per 3 ML Pen InjectorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652644insulin lispro 100 UNT/ML per 3 ML CartridgeSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1652639insulin lispro 100 UNT/ML per 3 ML Pen InjectorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621571insulin lispro 100 UNT/ML per 3 ML Pen Injector with SensorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
1926331insulin lispro 100 UNT/ML per 3 ML Pen Injector, 0.5 UNT DosesSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
2621571insulin lispro 300 UNT per 3 ML Pen Injector with SensorSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86
242120insulin, analog lispro 100 UNT/ML Injectable SolutionSYc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-8213-01000028213013 mL in 1 SYRINGE3 mlHistorical
0002-8213-05000028213055 SYRINGE in 1 CARTON (0002-8213-05) / 3 mL in 1 SYRINGE (0002-8213-01) 5 syringe2019-11-152027-04-04NoNoCurrent