FDA.reportPublic FDA data

Insulin Lispro

Product NDC
50090-5391
11-digit product format
500905391
Labeler code
50090
Product ID
50090-5391_9a40f3c1-7d33-48fd-b73b-f4d03ed24bc8
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
2020-02-12
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
Insulin Lispro
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
242120Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2be14cbb-197a-4da8-82c8-2443594e7f6fAvailable 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
50090-5391-02023-02-07C16284748780-1f386c649-b652-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INSULIN LISPRO safely and effectively. See full prescribing information for INSULIN LISPRO. INSULIN LISPRO injection, for subcutaneous or intravenous use Initial U.S. Approval: 1996 This product is HUMALOG® (insulin lispro).
50090-5391-02023-01-30C16284748780-1f386c649-b652-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INSULIN LISPRO safely and effectively. See full prescribing information for INSULIN LISPRO. INSULIN LISPRO injection, for subcutaneous or intravenous use Initial U.S. Approval: 1996 This product is HUMALOG® (insulin lispro).

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5391-0Insulin Lispro10 mL in 1 VIALINJECTION, SOLUTION107
50090-5391-0Insulin Lispro1 in 1 CARTONINJECTION, SOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5391-0ML - Milliliter50090-5391e3607091-a4e8-4a85-994d-4eb897e5651912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5391INSULIN LISPRO INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20240601_2be14cbb-197a-4da8-82c8-2443594e7f6f.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
ndc (product): 50090-5391
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

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
242120insulin lispro 100 UNT/ML Injectable SolutionPSN2be14cbb-197a-4da8-82c8-2443594e7f6f7
242120insulin lispro 100 UNT/ML Injectable SolutionSCD2be14cbb-197a-4da8-82c8-2443594e7f6f7
242120insulin, analog lispro 100 UNT/ML Injectable SolutionSY2be14cbb-197a-4da8-82c8-2443594e7f6f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5391-0500905391001 VIAL in 1 CARTON (50090-5391-0) / 10 mL in 1 VIAL1 vial2020-11-240000-00-00NoNoCurrent