Humalog
These highlights do not include all the information needed to use HUMALOG MIX50/50 safely and effectively. See full prescribing information for HUMALOG MIX50/50.HUMALOG MIX50/50 (insulin lispro protamine and insulin lispro) injectable suspension, for subcutaneous useInitial U.S. Approval: 1999
Approved
Approval ID
b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Eli Lilly and Company
DUNS: 006421325
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Insulin lispro
PRODUCT DETAILS
NDC Product Code0002-7512
Application NumberBLA021018
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 21, 2023
Generic NameInsulin lispro
INGREDIENTS (10)
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Insulin lisproActive
Quantity: 100 [iU] in 1 mL
Code: GFX7QIS1II
Classification: ACTIB
Protamine sulfateInactive
Quantity: 0.19 mg in 1 mL
Code: 0DE9724IHC
Classification: IACT
GlycerinInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
Sodium Phosphate, Dibasic, Unspecified FormInactive
Quantity: 3.78 mg in 1 mL
Code: GR686LBA74
Classification: IACT
MetacresolInactive
Quantity: 2.2 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
Zinc oxideInactive
Quantity: .0305 mg in 1 mL
Code: SOI2LOH54Z
Classification: IACT
PhenolInactive
Quantity: .89 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Insulin lispro
PRODUCT DETAILS
NDC Product Code0002-8798
Application NumberBLA021018
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 21, 2023
Generic NameInsulin lispro
INGREDIENTS (10)
Protamine sulfateInactive
Quantity: 0.19 mg in 1 mL
Code: 0DE9724IHC
Classification: IACT
GlycerinInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
Sodium Phosphate, Dibasic, Unspecified FormInactive
Quantity: 3.78 mg in 1 mL
Code: GR686LBA74
Classification: IACT
MetacresolInactive
Quantity: 2.2 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
Insulin lisproActive
Quantity: 100 [iU] in 1 mL
Code: GFX7QIS1II
Classification: ACTIB
Zinc oxideInactive
Quantity: .0305 mg in 1 mL
Code: SOI2LOH54Z
Classification: IACT
PhenolInactive
Quantity: .89 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT