FDA.reportPublic FDA data

Humalog

Product NDC
50090-1663
11-digit product format
500901663
Labeler code
50090
Product ID
50090-1663_634b4630-2dc7-4cae-9af1-036da98c608a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Insulin lispro
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA020563
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
KwikPen
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGFX7QIS1II
Rxcui242120, 865098, 1652639, 1652640

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1663-02023-02-07C16284748780-1f386c649-fc2b-0266-e053-dadaa90a7c1aThese 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
50090-1663-02023-01-30C16284748780-1f386c649-fc2b-0266-e053-dadaa90a7c1aThese 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
50090-1663-0HumalogKwikPen5 in 1 CARTONINJECTION, SOLUTION524
50090-1663-0HumalogKwikPen3 mL in 1 SYRINGEINJECTION, SOLUTION324

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1663-0ML - Milliliter50090-1663dee971f4-6e28-4c6c-846c-d3cc6e3eb5c312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1663HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]24Current NDC, Legacy NDC, 2 package rows20250406_c6b8ff07-d3e2-457f-8a38-b60de60adf75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1652640HumaLOG 100 UNT/ML in 3 ML Pen InjectorPSNc6b8ff07-d3e2-457f-8a38-b60de60adf7524
865098HumaLOG 100 UNT/ML Injectable SolutionPSNc6b8ff07-d3e2-457f-8a38-b60de60adf7524
1652639insulin lispro 100 UNT/ML in 3 ML Pen InjectorPSNc6b8ff07-d3e2-457f-8a38-b60de60adf7524
242120insulin lispro 100 UNT/ML Injectable SolutionPSNc6b8ff07-d3e2-457f-8a38-b60de60adf7524
16526403 ML insulin lispro 100 UNT/ML Pen Injector [Humalog]SBDc6b8ff07-d3e2-457f-8a38-b60de60adf7524
865098insulin lispro 100 UNT/ML Injectable Solution [Humalog]SBDc6b8ff07-d3e2-457f-8a38-b60de60adf7524
16526393 ML insulin lispro 100 UNT/ML Pen InjectorSCDc6b8ff07-d3e2-457f-8a38-b60de60adf7524
242120insulin lispro 100 UNT/ML Injectable SolutionSCDc6b8ff07-d3e2-457f-8a38-b60de60adf7524
16526403 ML Humalog 100 UNT/ML Pen InjectorSYc6b8ff07-d3e2-457f-8a38-b60de60adf7524
865098Humalog 100 UNT/ML Injectable SolutionSYc6b8ff07-d3e2-457f-8a38-b60de60adf7524
1652640Humalog KwikPen 100 UNT/ML per 3 ML Pen InjectorSYc6b8ff07-d3e2-457f-8a38-b60de60adf7524
1652639insulin lispro 100 UNT/ML per 3 ML Pen InjectorSYc6b8ff07-d3e2-457f-8a38-b60de60adf7524
242120insulin, analog lispro 100 UNT/ML Injectable SolutionSYc6b8ff07-d3e2-457f-8a38-b60de60adf7524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1663-0500901663005 SYRINGE in 1 CARTON (50090-1663-0) / 3 mL in 1 SYRINGE5 syringe2015-01-230000-00-00NoNoCurrent