NDC Code(s) : 73070-200-11, 73070-203-10, 73070-203-15
Packager : Novo Nordisk Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Insulin Aspart Protamine and Insulin Aspart insulin aspart INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73070-200
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN ASPART(UNII: D933668QVX)
(insulin aspart - UNII:D933668QVX) 		INSULIN ASPART100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)1.25 mg in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
GLYCERIN(UNII: PDC6A3C0OX)16.0 mg in 1 mL
METACRESOL(UNII: GGO4Y809LO)1.72 mg in 1 mL
PHENOL(UNII: 339NCG44TV)1.5 mg in 1 mL
PROTAMINE SULFATE(UNII: 0DE9724IHC)0.32 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)0.877 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ZINC(UNII: J41CSQ7QDS)19.6 ug in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:73070-200-111 in 1 CARTON 09/10/2019
110 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA021172 11/01/2001
Insulin Aspart Protamine and Insulin Aspart insulin aspart INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73070-203
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN ASPART(UNII: D933668QVX)
(insulin aspart - UNII:D933668QVX) 		INSULIN ASPART100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)1.25 mg in 1 mL
GLYCERIN(UNII: PDC6A3C0OX)16 mg in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
METACRESOL(UNII: GGO4Y809LO)1.72 mg in 1 mL
PHENOL(UNII: 339NCG44TV)1.5 mg in 1 mL
PROTAMINE SULFATE(UNII: 0DE9724IHC)0.32 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)0.877 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ZINC(UNII: J41CSQ7QDS)19.6 ug in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:73070-203-155 in 1 CARTON 09/10/2019
1NDC:73070-203-103 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA021172 09/11/2002

LABELER - Novo Nordisk Pharma, Inc.(117032563)

PRINCIPAL DISPLAY PANEL

NDC 73070-200-11

List 020011

Insulin Aspart Protamine and Insulin Aspart

injectable suspension

100 units/mL (U-100)

This product is NovoLog® Mix 70/30.

For subcutaneous use.

Shake carefully before using.

See enclosed insert for proper technique.

Rx only

Use only with a U-100 syringe.

10 mL multiple-dose vial

Vial Carton 8-0946-31-310-4

PRINCIPAL DISPLAY PANEL

  •  NDC 73070-203-15List 020315

Insulin Aspart Protamine

and Insulin Aspart

injectable suspension

FlexPen® Prefilled Pen

For Single Patient Use Only

100 units/mL (U-100)

This product is NovoLog® Mix 70/30.

5x3 mL prefilled pens

For subcutaneous use.

Shake carefully before using.

See enclosed insert for proper technique.

For use with NovoFine®, NovoFine® Plus or NovoTwist® disposable needles.

Store refrigerated at 2°C to 8°C (36°F to 46°F) until first use. After first use store at room temperature (up to 30°C [86°F]) and discard after 14 days. Avoid freezing. Protect from light.

Dispense in this sealed carton.

Rx only

FlexPen Carton 8-9674-31-310-7