FDA.reportPublic FDA data

Humalog

Product NDC
0002-8798
11-digit product format
000028798
Labeler code
0002
Product ID
0002-8798_68646c94-50c7-4474-9301-250eb73e3aea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Insulin lispro
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA021018
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Humalog
Brand name suffix
Mix50/50 KwikPen
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGFX7QIS1II
Rxcui260265, 731281, 847211, 847213

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
0002-8798-01Humalog Mix50/50 KwikPen3 mL in 1 SYRINGEINJECTION, SUSPENSION354
0002-8798-59Humalog Mix50/50 KwikPen5 in 1 CARTONINJECTION, SUSPENSION554
0002-8798-99Humalog Mix50/50 KwikPen3 mL in 1 SYRINGEINJECTION, SUSPENSION354
0002-8798-99Humalog Mix50/50 KwikPen1 in 1 CARTONINJECTION, SUSPENSION154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-8798-01ML - Milliliter0002-879863f1978b-6f04-4ae7-84b6-179eb78cf27612012-07-24
0002-8798-59ML - Milliliter0002-87987732bc6a-835d-47c6-88b6-a719f0ba688512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Insulin lisproACTIVE INGREDIENTGFX7QIS1IIHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
Insulin lisproACTIVE MOIETYGFX7QIS1IIHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
GlycerinINACTIVE INGREDIENTPDC6A3C0OXHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
MetacresolINACTIVE INGREDIENTGGO4Y809LOHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
PhenolINACTIVE INGREDIENT339NCG44TVHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
Protamine sulfateINACTIVE INGREDIENT0DE9724IHCHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
WaterINACTIVE INGREDIENT059QF0KO0RHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
ZincINACTIVE INGREDIENTJ41CSQ7QDSHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-8798HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]53Current NDC, Legacy NDC, 4 package rows20241215_b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847213HumaLOG Mix 50/50 in 3 ML Pen InjectorPSNb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
731281HumaLOG Mix 50/50 Injectable SuspensionPSNb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
847211insulin lispro protamine / insulin lispro 50/50 in 3 ML Pen InjectorPSNb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
260265insulin lispro protamine / insulin lispro 50/50 Injectable SuspensionPSNb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
8472133 ML insulin lispro 50 UNT/ML / insulin lispro protamine, human 50 UNT/ML Pen Injector [Humalog Mix]SBDb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
731281insulin lispro 50 UNT/ML / insulin lispro protamine, human 50 UNT/ML Injectable Suspension [Humalog Mix]SBDb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
8472113 ML insulin lispro 50 UNT/ML / insulin lispro protamine, human 50 UNT/ML Pen InjectorSCDb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
260265insulin lispro 50 UNT/ML / insulin lispro protamine, human 50 UNT/ML Injectable SuspensionSCDb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
731281Humalog Mix 50/50 100 UNT/ML Injectable SuspensionSYb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
847213Humalog Mix 50/50 300 UNT per 3 ML KwikPenSYb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
847213Humalog Mix 50/50 300 UNT per 3 ML Prefilled PenSYb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
260265insulin analog, lispro mixed 50/50 100 UNT/ML Injectable SuspensionSYb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
847211insulin lispro protamine 150 UNT / insulin lispro 150 UNT per 3 ML Pen InjectorSYb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-8798-01000028798013 mL in 1 SYRINGE3 mlHistorical
0002-8798-59000028798595 SYRINGE in 1 CARTON (0002-8798-59) / 3 mL in 1 SYRINGE (0002-8798-01) 5 syringe2008-01-160000-00-00NoNoCurrent
0002-8798-99000028798991 SYRINGE in 1 CARTON (0002-8798-99) > 3 mL in 1 SYRINGE1 syringe2008-01-160000-00-00YesNoCurrent