FDA.reportPublic FDA data

Insulin Lispro Protamine and Insulin Lispro Injectable Suspension

Product NDC
0002-8233
11-digit product format
000028233
Labeler code
0002
Product ID
0002-8233_03dce3f6-da85-4635-9c62-478226005b60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Insulin lispro
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA021017
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 Protamine and Insulin Lispro Injectable Suspension
Brand name suffix
Mix75/25 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
847252Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e49f701d-c19f-4cb2-b63f-01a917b33abcAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-8233-01Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen3 mL in 1 SYRINGEINJECTION, SUSPENSION311
0002-8233-05Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen5 in 1 CARTONINJECTION, SUSPENSION511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-8233-01ML - Milliliter0002-82334a2fed7b-72a3-4e42-8e76-f48c3c1a3e7b12020-04-20
0002-8233-05ML - Milliliter0002-8233d0f86a34-6362-454b-9fdf-b12594c4825c12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-8233INSULIN LISPRO PROTAMINE AND INSULIN LISPRO INJECTABLE SUSPENSION MIX75/25 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]11Current NDC, Legacy NDC, 2 package rows20240809_e49f701d-c19f-4cb2-b63f-01a917b33abc.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPenINSULIN LISPROEli Lilly and Companye49f701d-c19f-4cb2-b63f-01a917b33abc2024-08-06Warnings, Adverse reactionsExact identifier
application number: BLA021017
ndc (product): 0002-8233
Humalog Mix75/25 KwikPenINSULIN LISPROEli Lilly and Companyc73da51a-1899-45ad-b6cf-9c52c36a25dd2024-08-06Warnings, Adverse reactionsExact identifier
application number: BLA021017

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021017Humalog Mix 75/25insulin lispro protamine and insulin lispro351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847252insulin lispro protamine / insulin lispro 75/25 in 3 ML Pen InjectorPSNe49f701d-c19f-4cb2-b63f-01a917b33abc11
8472523 ML insulin lispro 25 UNT/ML / insulin lispro protamine, human 75 UNT/ML Pen InjectorSCDe49f701d-c19f-4cb2-b63f-01a917b33abc11
847252insulin lispro protamine 75 UNT/ML / insulin lispro 25 UNT/ML per 3 ML Pen InjectorSYe49f701d-c19f-4cb2-b63f-01a917b33abc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-8233-01000028233013 mL in 1 SYRINGE3 mlHistorical
0002-8233-05000028233055 SYRINGE in 1 CARTON (0002-8233-05) / 3 mL in 1 SYRINGE (0002-8233-01) 5 syringe2020-02-120000-00-00NoNoCurrent