NOVOLOG
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
Approved
Approval ID
13891e5a-e57a-46e8-911c-2f680352b52b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
insulin aspart
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-4500
Application NumberBLA020986
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin aspart
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (9)
INSULIN ASPARTActive
Quantity: 100 [iU] in 1 mL
Code: D933668QVX
Classification: ACTIB
GLYCERINInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 1.25 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METACRESOLInactive
Quantity: 1.72 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
PHENOLInactive
Quantity: 1.5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.58 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ZINCInactive
Quantity: 19.6 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT