Insulin Aspart Protamine and Insulin Aspart
These highlights do not include all the information needed to use INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 safely and effectively. See full prescribing information for INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30. INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 injectable suspension, for subcutaneous useInitial U.S. Approval: 2001This product is NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart).
Approved
Approval ID
fc94baa4-3606-48bc-a781-9617ab6960ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2023
Manufacturers
FDA
Novo Nordisk Pharma, Inc.
DUNS: 117032563
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
insulin aspart
PRODUCT DETAILS
NDC Product Code73070-200
Application NumberBLA021172
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 30, 2020
Generic Nameinsulin aspart
INGREDIENTS (10)
GLYCERINInactive
Quantity: 16.0 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
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
INSULIN ASPARTActive
Quantity: 100 [iU] in 1 mL
Code: D933668QVX
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PROTAMINE SULFATEInactive
Quantity: 0.32 mg in 1 mL
Code: 0DE9724IHC
Classification: IACT
PHENOLInactive
Quantity: 1.5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.877 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
NDC Product Code73070-203
Application NumberBLA021172
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 30, 2020
Generic Nameinsulin aspart
INGREDIENTS (10)
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: 0.877 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
PROTAMINE SULFATEInactive
Quantity: 0.32 mg in 1 mL
Code: 0DE9724IHC
Classification: IACT
ZINCInactive
Quantity: 19.6 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT