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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1652639Internal RxNorm lookup
1652640Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
51d3dc11-52b9-4296-a2f4-58c770d4448dAvailable 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

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

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Humalog KwikPenINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-01-09Warnings, Adverse reactionsExact identifier
application number: BLA020563
Insulin LisproINSULIN LISPROEli Lilly and Company97d5e596-aae1-42c9-ae89-c3780959c4672025-06-17Warnings, Adverse reactionsExact identifier
application number: BLA020563
HUMALOGINSULIN LISPROA-S Medication Solutionsc6b8ff07-d3e2-457f-8a38-b60de60adf752025-04-01Warnings, Adverse reactionsExact identifier
application number: BLA020563
Insulin LisproINSULIN LISPROA-S Medication Solutions2be14cbb-197a-4da8-82c8-2443594e7f6f2024-05-31Warnings, Adverse reactionsExact identifier
application number: BLA020563
HUMALOGINSULIN LISPROA-S Medication Solutions6ee01d2e-3525-4aa9-8ec1-5fb0f63dd47c2024-02-15Warnings, Adverse reactionsExact identifier
application number: BLA020563
Humalog KwikPenINSULIN LISPROA-S Medication Solutions51d3dc11-52b9-4296-a2f4-58c770d4448d2024-01-24Warnings, Adverse reactionsExact identifier
application number: BLA020563
ndc (product): 50090-4073

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020563Humaloginsulin lispro351(a)Rx2026-07-01

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