MedPath

NOVOLOG MIX 70/30

These highlights do not include all the information needed to use NOVOLOG MIX 70/30 safely and effectively. See full prescribing information for NOVOLOG MIX 70/30. NOVOLOG MIX 70/30 (insulin aspart protamine and insulin aspart) injectable suspension, for subcutaneous useInitial U.S. Approval: 2001

Approved
Approval ID

ead74453-dd15-4836-8ad6-5b14ac168d02

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 24, 2024

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 Code50090-4085
Application NumberBLA021172
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin aspart
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 28, 2021
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
PHENOLInactive
Quantity: 1.5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
METACRESOLInactive
Quantity: 1.72 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
PROTAMINE SULFATEInactive
Quantity: 0.32 mg in 1 mL
Code: 0DE9724IHC
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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

NOVOLOG MIX 70/30 - FDA Drug Approval Details