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

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 packagepackage0002-87970002-8797-61DDiscontinued by firm2026-08-11

Additional Listing Data#

Finished product
Yes
Brand name base
Humalog
Brand name suffix
Mix75/25 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
c73da51a-1899-45ad-b6cf-9c52c36a25ddAvailable 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
0002-8797-01Humalog 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-8797-01ML - Milliliter0002-87976065feb2-5b13-4221-bbe3-4f57e18753bc12012-07-24
0002-8797-59ML - Milliliter0002-879706a06939-f249-485e-9b48-d5773d58941312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Insulin lisproACTIVE INGREDIENTGFX7QIS1IIHUMALOG MIX75/25 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX75/25 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY ]31
Insulin lisproACTIVE MOIETYGFX7QIS1IIHUMALOG MIX75/25 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX75/25 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY ]31
GlycerinINACTIVE INGREDIENTPDC6A3C0OXHUMALOG MIX75/25 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX75/25 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY ]31
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBHUMALOG MIX75/25 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX75/25 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY ]31
MetacresolINACTIVE INGREDIENTGGO4Y809LOHUMALOG MIX75/25 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX75/25 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY ]31
PhenolINACTIVE INGREDIENT339NCG44TVHUMALOG MIX75/25 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX75/25 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY ]31
Protamine sulfateINACTIVE INGREDIENT0DE9724IHCHUMALOG MIX75/25 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX75/25 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY ]31
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IHUMALOG MIX75/25 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX75/25 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY ]31
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74HUMALOG MIX75/25 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX75/25 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY ]31
WaterINACTIVE INGREDIENT059QF0KO0RHUMALOG MIX75/25 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX75/25 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY ]31
ZincINACTIVE INGREDIENTJ41CSQ7QDSHUMALOG MIX75/25 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX75/25 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY ]31

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPenINSULIN LISPROEli Lilly and Companye49f701d-c19f-4cb2-b63f-01a917b33abc2024-08-06Warnings, Adverse reactionsExact identifier
application number: BLA021017
Humalog Mix75/25 KwikPenINSULIN LISPROEli Lilly and Companyc73da51a-1899-45ad-b6cf-9c52c36a25dd2024-08-06Warnings, Adverse reactionsExact identifier
application number: BLA021017
ndc (product): 0002-8797

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021017Humalog Mix 75/25insulin lispro protamine and insulin lispro351(a)Rx2026-07-01

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