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
3a1e73a2-3009-40d0-876c-b4cb2be56fc5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2023
Manufacturers
FDA
Novo Nordisk
DUNS: 622920320
Products 7
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 Code0169-2101
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
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 1.25 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
GLYCERINInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
METACRESOLInactive
Quantity: 1.72 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.58 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Quantity: 1.5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
ZINCInactive
Quantity: 19.6 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
water injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-2001
Application NumberBLA020986
Product Classification
M
Marketing Category
C73585
G
Generic Name
water injection
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (7)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERActive
Quantity: 1 mL in 1 mL
Code: 059QF0KO0R
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PHENOLInactive
Quantity: 0.65 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
METACRESOLInactive
Quantity: 1.5 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
insulin aspart
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-7501
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
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 1.25 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
GLYCERINInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.58 mg in 1 mL
Code: 451W47IQ8X
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
ZINCInactive
Quantity: 19.6 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
insulin aspart
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-2100
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
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 1.25 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
GLYCERINInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
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
METACRESOLInactive
Quantity: 1.72 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ZINCInactive
Quantity: 19.6 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
insulin aspart
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-6338
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
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
GLYCERINInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
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
insulin aspart
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-6339
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
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 1.25 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
GLYCERINInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
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 HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.58 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ZINCInactive
Quantity: 19.6 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
insulin aspart
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-3303
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
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 1.25 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
GLYCERINInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
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