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Insulin Lispro

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

Approved
Approval ID

97d5e596-aae1-42c9-ae89-c3780959c467

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 21, 2023

Manufacturers
FDA

Eli Lilly and Company

DUNS: 006421325

Products 3

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 Code0002-7752
Application NumberBLA020563
Product Classification
M
Marketing Category
C73585
G
Generic Name
Insulin lispro
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 21, 2023
FDA Product Classification

INGREDIENTS (9)

GlycerinInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
MetacresolInactive
Quantity: 3.15 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
Insulin lisproActive
Quantity: 100 [iU] in 1 mL
Code: GFX7QIS1II
Classification: ACTIB
PhenolInactive
Code: 339NCG44TV
Classification: IACT
Sodium Phosphate, Dibasic, Unspecified FormInactive
Quantity: 1.88 mg in 1 mL
Code: GR686LBA74
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
ZincInactive
Quantity: .0197 mg in 1 mL
Code: J41CSQ7QDS
Classification: IACT

Insulin lispro

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0002-8222
Application NumberBLA020563
Product Classification
M
Marketing Category
C73585
G
Generic Name
Insulin lispro
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJuly 21, 2023
FDA Product Classification

INGREDIENTS (9)

GlycerinInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
Insulin lisproActive
Quantity: 100 [iU] in 1 mL
Code: GFX7QIS1II
Classification: ACTIB
Sodium Phosphate, Dibasic, Unspecified FormInactive
Quantity: 1.88 mg in 1 mL
Code: GR686LBA74
Classification: IACT
MetacresolInactive
Quantity: 3.15 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
ZincInactive
Quantity: .0197 mg in 1 mL
Code: J41CSQ7QDS
Classification: IACT
PhenolInactive
Code: 339NCG44TV
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT

Insulin lispro

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0002-7737
Application NumberBLA020563
Product Classification
M
Marketing Category
C73585
G
Generic Name
Insulin lispro
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJuly 21, 2023
FDA Product Classification

INGREDIENTS (9)

Insulin lisproActive
Quantity: 100 [iU] in 1 mL
Code: GFX7QIS1II
Classification: ACTIB
Sodium Phosphate, Dibasic, Unspecified FormInactive
Quantity: 1.88 mg in 1 mL
Code: GR686LBA74
Classification: IACT
GlycerinInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
ZincInactive
Quantity: .0197 mg in 1 mL
Code: J41CSQ7QDS
Classification: IACT
PhenolInactive
Code: 339NCG44TV
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
MetacresolInactive
Quantity: 3.15 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT

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