FDA.reportPublic FDA data

Humalog

Product NDC
50090-4073
11-digit product format
500904073
Labeler code
50090
Product ID
50090-4073_a2a2e9c9-1832-4a68-b5e4-ba62d7b66df2
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
Rxcui1652639, 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
50090-4073-02023-02-07C16284748780-1f386c64a-3796-0266-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
50090-4073-02023-01-30C16284748780-1f386c64a-3796-0266-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
50090-4073-0HumalogKwikPen3 mL in 1 SYRINGEINJECTION, SOLUTION37
50090-4073-0HumalogKwikPen5 in 1 CARTONINJECTION, SOLUTION57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4073-0ML - Milliliter50090-407394d30c2e-8a86-430a-ab46-09bdc6301a0b12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4073HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20240627_51d3dc11-52b9-4296-a2f4-58c770d4448d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1652640HumaLOG 100 UNT/ML in 3 ML Pen InjectorPSN51d3dc11-52b9-4296-a2f4-58c770d4448d7
1652639insulin lispro 100 UNT/ML in 3 ML Pen InjectorPSN51d3dc11-52b9-4296-a2f4-58c770d4448d7
16526403 ML insulin lispro 100 UNT/ML Pen Injector [Humalog]SBD51d3dc11-52b9-4296-a2f4-58c770d4448d7
16526393 ML insulin lispro 100 UNT/ML Pen InjectorSCD51d3dc11-52b9-4296-a2f4-58c770d4448d7
16526403 ML Humalog 100 UNT/ML Pen InjectorSY51d3dc11-52b9-4296-a2f4-58c770d4448d7
1652640Humalog KwikPen 100 UNT/ML per 3 ML Pen InjectorSY51d3dc11-52b9-4296-a2f4-58c770d4448d7
1652639insulin lispro 100 UNT/ML per 3 ML Pen InjectorSY51d3dc11-52b9-4296-a2f4-58c770d4448d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4073-0500904073005 SYRINGE in 1 CARTON (50090-4073-0) / 3 mL in 1 SYRINGE5 syringe2019-01-210000-00-00NoNoCurrent