FDA.reportPublic FDA data

Insulin Lispro

Product NDC
0002-8222
11-digit product format
000028222
Labeler code
0002
Product ID
0002-8222_6329aa6b-3571-4196-83b0-fc99de56f3ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Insulin lispro
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Eli Lilly and Company
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
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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
242120Internal RxNorm lookup
1652639Internal RxNorm lookup
1926331Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
97d5e596-aae1-42c9-ae89-c3780959c467Available 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
0002-8222-592024-01-30C16284748780-11030e365-2939-111a-e063-dadaa90a10e2These 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
0002-8222-01Insulin Lispro KwikPen3 mL in 1 SYRINGEINJECTION, SOLUTION312
0002-8222-59Insulin Lispro KwikPen5 in 1 CARTONINJECTION, SOLUTION512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-8222-01ML - Milliliter0002-822265d5617b-5b18-473f-a2c0-625cc781162312020-06-05
0002-8222-59ML - Milliliter0002-822201d65c0e-248a-4abf-ada8-7b553fd4267c12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-8222INSULIN LISPRO INJECTION, SOLUTION INSULIN LISPRO KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION INSULIN LISPRO JUNIOR KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]11Current NDC, Legacy NDC, 2 package rows20241213_97d5e596-aae1-42c9-ae89-c3780959c467.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
ndc (product): 0002-8222
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

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
1652639insulin lispro 100 UNT/ML in 3 ML Pen InjectorPSN97d5e596-aae1-42c9-ae89-c3780959c46712
1926331insulin lispro 100 UNT/ML in 3 ML Pen Injector, 0.5 UNT DosesPSN97d5e596-aae1-42c9-ae89-c3780959c46712
242120insulin lispro 100 UNT/ML Injectable SolutionPSN97d5e596-aae1-42c9-ae89-c3780959c46712
19263310.5 UNT Doses 3 ML insulin lispro 100 UNT/ML Pen InjectorSCD97d5e596-aae1-42c9-ae89-c3780959c46712
16526393 ML insulin lispro 100 UNT/ML Pen InjectorSCD97d5e596-aae1-42c9-ae89-c3780959c46712
242120insulin lispro 100 UNT/ML Injectable SolutionSCD97d5e596-aae1-42c9-ae89-c3780959c46712
1652639insulin lispro 100 UNT/ML per 3 ML Pen InjectorSY97d5e596-aae1-42c9-ae89-c3780959c46712
1926331insulin lispro 100 UNT/ML per 3 ML Pen Injector, 0.5 UNT DosesSY97d5e596-aae1-42c9-ae89-c3780959c46712
242120insulin, analog lispro 100 UNT/ML Injectable SolutionSY97d5e596-aae1-42c9-ae89-c3780959c46712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-8222-01000028222013 mL in 1 SYRINGE3 mlHistorical
0002-8222-59000028222595 SYRINGE in 1 CARTON (0002-8222-59) / 3 mL in 1 SYRINGE (0002-8222-01) 5 syringe2020-02-120000-00-00NoNoCurrent