Humalog

Basic Information

Product Name

Humalog

FDA Product Code

0002-7510

Regulatory Information

NDC Product Code

0002-7510

Application Number

BLA020563

Marketing Category

C73585

Effective Date

August 2, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use HUMALOG safely and effectively. See full prescribing information for HUMALOG. HUMALOG (insulin lispro) injection, for subcutaneous or intravenous use Initial U.S. Approval: 1996

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

Insulin lispro

Quantity: 100 [iU] in 1 mL

Code: GFX7QIS1II

Class Code: ACTIB

Glycerin

Quantity: 16 mg in 1 mL

Code: PDC6A3C0OX

Class Code: IACT

Zinc

Quantity: .0197 mg in 1 mL

Code: J41CSQ7QDS

Class Code: IACT

Metacresol

Quantity: 3.15 mg in 1 mL

Code: GGO4Y809LO

Class Code: IACT

Hydrochloric acid

Code: QTT17582CB

Class Code: IACT

Phenol

Code: 339NCG44TV

Class Code: IACT

Water

Code: 059QF0KO0R

Class Code: IACT

Sodium hydroxide

Code: 55X04QC32I

Class Code: IACT

Sodium Phosphate, Dibasic, Unspecified Form

Quantity: 1.0 mg in 1 mL

Code: GR686LBA74

Class Code: IACT

Active Moieties

Insulin lispro

Code: GFX7QIS1II

Basic Information

Regulatory Information

Company Information

Active Ingredients

Glycerin

Zinc

Metacresol

Hydrochloric acid

Phenol

Water

Sodium hydroxide

Sodium Phosphate, Dibasic, Unspecified Form

Active Moieties

Insulin lispro