FDA.reportPublic FDA data

Humalog

Product NDC
0002-7512
11-digit product format
000027512
Labeler code
0002
Product ID
0002-7512_b2e34993-838d-4e33-bf5e-c9fa4920a536
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Insulin lispro
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA021018
Marketing category
BLA
Marketing start
1999-12-22
Marketing end
0000-00-00
Substance
INSULIN LISPRO
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
0002-7512-01Humalog Mix50/5010 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION1054
0002-7512-01Humalog Mix50/501 in 1 CARTONINJECTION, SUSPENSION154
0002-7512-99Humalog Mix50/501 in 1 CARTONINJECTION, SUSPENSION154
0002-7512-99Humalog Mix50/5010 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION1054

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-7512-01ML - Milliliter0002-7512de85e37d-ca0d-4ba8-8577-37dd18bea03312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Insulin lisproACTIVE INGREDIENTGFX7QIS1IIHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
Insulin lisproACTIVE MOIETYGFX7QIS1IIHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
GlycerinINACTIVE INGREDIENTPDC6A3C0OXHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
MetacresolINACTIVE INGREDIENTGGO4Y809LOHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
PhenolINACTIVE INGREDIENT339NCG44TVHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
Protamine sulfateINACTIVE INGREDIENT0DE9724IHCHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
WaterINACTIVE INGREDIENT059QF0KO0RHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32
ZincINACTIVE INGREDIENTJ41CSQ7QDSHUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-7512HUMALOG MIX50/50 (INSULIN LISPRO) INJECTION, SUSPENSION HUMALOG MIX50/50 KWIKPEN (INSULIN LISPRO) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]53Legacy NDC, 4 package rows20241215_b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847213HumaLOG Mix 50/50 in 3 ML Pen InjectorPSNb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
731281HumaLOG Mix 50/50 Injectable SuspensionPSNb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
847211insulin lispro protamine / insulin lispro 50/50 in 3 ML Pen InjectorPSNb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
260265insulin lispro protamine / insulin lispro 50/50 Injectable SuspensionPSNb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
8472133 ML insulin lispro 50 UNT/ML / insulin lispro protamine, human 50 UNT/ML Pen Injector [Humalog Mix]SBDb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
731281insulin lispro 50 UNT/ML / insulin lispro protamine, human 50 UNT/ML Injectable Suspension [Humalog Mix]SBDb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
8472113 ML insulin lispro 50 UNT/ML / insulin lispro protamine, human 50 UNT/ML Pen InjectorSCDb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
260265insulin lispro 50 UNT/ML / insulin lispro protamine, human 50 UNT/ML Injectable SuspensionSCDb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
731281Humalog Mix 50/50 100 UNT/ML Injectable SuspensionSYb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
847213Humalog Mix 50/50 300 UNT per 3 ML KwikPenSYb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
847213Humalog Mix 50/50 300 UNT per 3 ML Prefilled PenSYb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
260265insulin analog, lispro mixed 50/50 100 UNT/ML Injectable SuspensionSYb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54
847211insulin lispro protamine 150 UNT / insulin lispro 150 UNT per 3 ML Pen InjectorSYb34cd3ff-d0af-4852-b4ef-2a8b4a93aeae54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0002-7512-01000027512011 VIAL, MULTI-DOSE in 1 CARTON (0002-7512-01) > 10 mL in 1 VIAL, MULTI-DOSE2006-02-070000-00-00NoNoCurrent
0002-7512-99000027512991 VIAL, MULTI-DOSE in 1 CARTON (0002-7512-99) > 10 mL in 1 VIAL, MULTI-DOSE2006-10-190000-00-00YesNoCurrent