Insulin Aspart
This product is NovoLog (insulin aspart).
Approved
Approval ID
bee5b358-c863-420b-be73-ced2e920c499
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2023
Manufacturers
FDA
Novo Nordisk Pharma, Inc.
DUNS: 117032563
Products 3
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 Code73070-103
Application NumberBLA020986
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin aspart
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 15, 2019
FDA Product Classification
INGREDIENTS (9)
INSULIN ASPARTActive
Quantity: 100 [iU] in 1 mL
Code: D933668QVX
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
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
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 CHLORIDEInactive
Quantity: 0.58 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
METACRESOLInactive
Quantity: 1.72 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
insulin aspart
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73070-100
Application NumberBLA020986
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin aspart
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 15, 2019
FDA Product Classification
INGREDIENTS (9)
GLYCERINInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
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
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
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 Code73070-102
Application NumberBLA020986
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin aspart
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 15, 2019
FDA Product Classification
INGREDIENTS (9)
GLYCERINInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
INSULIN ASPARTActive
Quantity: 100 [iU] in 1 mL
Code: D933668QVX
Classification: ACTIB
METACRESOLInactive
Quantity: 1.72 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
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
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ZINCInactive
Quantity: 19.6 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 1.25 mg in 1 mL
Code: 94255I6E2T
Classification: IACT