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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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73070-200
Application NumberBLA021172
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin aspart
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 30, 2020
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73070-203
Application NumberBLA021172
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin aspart
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 30, 2020
FDA Product Classification

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

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