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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-7512
Application NumberBLA021018
Product Classification
M
Marketing Category
C73585
G
Generic Name
Insulin lispro
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 21, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-8798
Application NumberBLA021018
Product Classification
M
Marketing Category
C73585
G
Generic Name
Insulin lispro
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 21, 2023
FDA Product Classification
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