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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0002-87980002-8798-99DDiscontinued by firm2026-08-11

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GFX7QIS1IIInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b34cd3ff-d0af-4852-b4ef-2a8b4a93aeaeAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Humalog Mix50/50 KwikPenINSULIN LISPROEli Lilly and Companyb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae2026-01-13Warnings, Adverse reactionsExact identifier
application number: BLA021018
ndc (product): 0002-8798

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021018Humalog Mix 50/50insulin lispro protamine and insulin lispro351(a)Disc2026-07-01

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