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Insulin Lispro Protamine and Insulin Lispro Injectable Suspension

These highlights do not include all the information needed to use INSULIN LISPRO PROTAMINE AND INSULIN LISPRO MIX75/25 safely and effectively. See full prescribing information for INSULIN LISPRO PROTAMINE AND INSULIN LISPRO MIX75/25. INSULIN LISPRO PROTAMINE AND INSULIN LISPRO injectable suspension Mix75/25, for subcutaneous use Initial U.S. Approval: 1999 This product is HUMALOG Mix75/25™ (insulin lispro protamine and insulin lispro).

Approved
Approval ID

e49f701d-c19f-4cb2-b63f-01a917b33abc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 20, 2023

Manufacturers
FDA

Eli Lilly and Company

DUNS: 006421325

Products 1

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 Code0002-8233
Application NumberBLA021017
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)

MetacresolInactive
Quantity: 1.76 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
Protamine sulfateInactive
Quantity: 0.28 mg in 1 mL
Code: 0DE9724IHC
Classification: IACT
Insulin lisproActive
Quantity: 100 [iU] in 1 mL
Code: GFX7QIS1II
Classification: ACTIB
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
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Zinc oxideInactive
Quantity: .025 mg in 1 mL
Code: SOI2LOH54Z
Classification: IACT
PhenolInactive
Quantity: .715 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT

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