MedPath
FDA Product

NOVOLOG

Product approved by U.S. Food and Drug Administration (US)

Basic Information

NOVOLOG

0169-2101

Regulatory Information

0169-2101

BLA020986

C73585

February 28, 2023

USA

These highlights do not include all the information needed to use NOVOLOG safely and effectively. See full prescribing information for NOVOLOG.NOVOLOG (insulin aspart) injection, for subcutaneous or intravenous useInitial U.S. Approval: 2000

HUMAN PRESCRIPTION DRUG LABEL

33

Company Information

Novo Nordisk

622920320

Active Ingredients

INSULIN ASPART

Quantity: 100 [iU] in 1 mL

Code: D933668QVX

Class Code: ACTIB

SODIUM PHOSPHATE, DIBASIC, DIHYDRATE

Quantity: 1.25 mg in 1 mL

Code: 94255I6E2T

Class Code: IACT

GLYCERIN

Quantity: 16 mg in 1 mL

Code: PDC6A3C0OX

Class Code: IACT

METACRESOL

Quantity: 1.72 mg in 1 mL

Code: GGO4Y809LO

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

SODIUM CHLORIDE

Quantity: 0.58 mg in 1 mL

Code: 451W47IQ8X

Class Code: IACT

PHENOL

Quantity: 1.5 mg in 1 mL

Code: 339NCG44TV

Class Code: IACT

ZINC

Quantity: 19.6 ug in 1 mL

Code: J41CSQ7QDS

Class Code: IACT

Active Moieties

INSULIN ASPART

Code: D933668QVX

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