FDA.reportPublic FDA data

HUMALOG

Product NDC
50090-4488
11-digit product format
500904488
Labeler code
50090
Product ID
50090-4488_53d23f9f-69bb-43bb-9d90-0f8a89b68ae7
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
1996-06-14
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
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGFX7QIS1II
Rxcui242120, 865098

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
50090-4488-02023-02-07C16284748780-1f386c649-e9c4-0266-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
50090-4488-02023-01-30C16284748780-1f386c649-e9c4-0266-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
50090-4488-0HUMALOG10 mL in 1 VIALINJECTION, SOLUTION108
50090-4488-0HUMALOG1 in 1 CARTONINJECTION, SOLUTION18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4488HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20240217_6ee01d2e-3525-4aa9-8ec1-5fb0f63dd47c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865098HumaLOG 100 UNT/ML Injectable SolutionPSN6ee01d2e-3525-4aa9-8ec1-5fb0f63dd47c8
242120insulin lispro 100 UNT/ML Injectable SolutionPSN6ee01d2e-3525-4aa9-8ec1-5fb0f63dd47c8
865098insulin lispro 100 UNT/ML Injectable Solution [Humalog]SBD6ee01d2e-3525-4aa9-8ec1-5fb0f63dd47c8
242120insulin lispro 100 UNT/ML Injectable SolutionSCD6ee01d2e-3525-4aa9-8ec1-5fb0f63dd47c8
865098Humalog 100 UNT/ML Injectable SolutionSY6ee01d2e-3525-4aa9-8ec1-5fb0f63dd47c8
242120insulin, analog lispro 100 UNT/ML Injectable SolutionSY6ee01d2e-3525-4aa9-8ec1-5fb0f63dd47c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4488-0500904488001 VIAL in 1 CARTON (50090-4488-0) / 10 mL in 1 VIAL1 vial2019-08-290000-00-00NoNoCurrent