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 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) Suspension for subcutaneous injection Initial U.S. Approval: 2001
Approved
Approval ID
973a9333-fec7-46dd-8eb5-25738f06ee54
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5327
Application NumberNDA021172
Product Classification
M
Marketing Category
C73594
G
Generic Name
insulin aspart
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJune 15, 2011
FDA Product Classification
INGREDIENTS (10)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 1.25 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
INSULIN ASPARTActive
Quantity: 100 [iU] in 1 mL
Code: D933668QVX
Classification: ACTIB
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: 0.877 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ZINCInactive
Quantity: 19.6 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
PROTAMINE SULFATEInactive
Quantity: 0.32 mg in 1 mL
Code: 0DE9724IHC
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
insulin aspart
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5201
Application NumberNDA021172
Product Classification
M
Marketing Category
C73594
G
Generic Name
insulin aspart
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJune 15, 2011
FDA Product Classification
INGREDIENTS (10)
MANNITOLInactive
Quantity: 36.4 mg in 1 mL
Code: 3OWL53L36A
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
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
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
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