FDA.reportPublic FDA data

Humalog

Product NDC
0002-8797
11-digit product format
000028797
Labeler code
0002
Product ID
0002-8797_e67019bc-6512-412d-9c1b-23f898c33f41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Insulin lispro
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA021017
Marketing category
BLA
Marketing start
2007-09-06
Substance
INSULIN LISPRO
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Humalog
Brand name suffix
Mix75/25 KwikPen
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGFX7QIS1II
Rxcui259111, 752388, 847252, 847254

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a42609d2-d76b-4c21-bc65-ace5fa0da69dProduct name120210105
0c5ba5d1-c81f-5bcc-49a8-b8e264edfb14Product name320200325
4477e8cc-8057-4880-8829-dfea528a2efaProduct name220200325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-8797-01Humalog Mix75/25 KwikPen3 mL in 1 SYRINGEINJECTION, SUSPENSION353
0002-8797-59Humalog Mix75/25 KwikPen5 in 1 CARTONINJECTION, SUSPENSION553
0002-8797-61Humalog Mix75/25 KwikPen3 mL in 1 SYRINGEINJECTION, SUSPENSION353
0002-8797-61Humalog Mix75/25 KwikPen1 in 1 CARTONINJECTION, SUSPENSION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-8797HUMALOG MIX75/25 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX75/25 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]53Current NDC, Legacy NDC, 4 package rows20240809_c73da51a-1899-45ad-b6cf-9c52c36a25dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
752388HumaLOG Mix 75/25 Injectable SuspensionPSNc73da51a-1899-45ad-b6cf-9c52c36a25dd53
847254HumaLOG Mix 75/25 UNT in 3 ML Pen InjectorPSNc73da51a-1899-45ad-b6cf-9c52c36a25dd53
847252insulin lispro protamine / insulin lispro 75/25 in 3 ML Pen InjectorPSNc73da51a-1899-45ad-b6cf-9c52c36a25dd53
259111insulin lispro protamine / insulin lispro 75/25 Injectable SuspensionPSNc73da51a-1899-45ad-b6cf-9c52c36a25dd53
8472543 ML insulin lispro 25 UNT/ML / insulin lispro protamine, human 75 UNT/ML Pen Injector [Humalog Mix]SBDc73da51a-1899-45ad-b6cf-9c52c36a25dd53
752388insulin lispro 25 UNT/ML / insulin lispro protamine, human 75 UNT/ML Injectable Suspension [Humalog Mix]SBDc73da51a-1899-45ad-b6cf-9c52c36a25dd53
8472523 ML insulin lispro 25 UNT/ML / insulin lispro protamine, human 75 UNT/ML Pen InjectorSCDc73da51a-1899-45ad-b6cf-9c52c36a25dd53
259111insulin lispro 25 UNT/ML / insulin lispro protamine, human 75 UNT/ML Injectable SuspensionSCDc73da51a-1899-45ad-b6cf-9c52c36a25dd53
847254Humalog Mix 75/25 300 UNT per 3 ML KwikPenSYc73da51a-1899-45ad-b6cf-9c52c36a25dd53
847254Humalog Mix 75/25 300 UNT per 3 ML PenSYc73da51a-1899-45ad-b6cf-9c52c36a25dd53
752388Humalog Mix 75/25 Injectable SuspensionSYc73da51a-1899-45ad-b6cf-9c52c36a25dd53
259111insulin analog, lispro mixed 75/25 100 UNT/ML Injectable SuspensionSYc73da51a-1899-45ad-b6cf-9c52c36a25dd53
847252insulin lispro protamine 75 UNT/ML / insulin lispro 25 UNT/ML per 3 ML Pen InjectorSYc73da51a-1899-45ad-b6cf-9c52c36a25dd53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-8797-01000028797013 mL in 1 SYRINGE3 mlHistorical
0002-8797-59000028797595 SYRINGE in 1 CARTON (0002-8797-59) / 3 mL in 1 SYRINGE (0002-8797-01) 5 syringe2008-01-160000-00-00NoNoCurrent
0002-8797-61000028797611 SYRINGE in 1 CARTON (0002-8797-61) / 3 mL in 1 SYRINGE1 syringe2017-10-010000-00-00YesNoCurrent