NDC Code(s) : 0169-3685-12, 0169-3685-92, 0169-3696-19, 0169-3696-97, 0169-3696-90, 0169-3696-98, 0169-2200-11, 0169-2201-25
Packager : Novo Nordisk

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NovoLog Mix 70/30insulin aspart INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-3685
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:0169-3685-121 in 1 CARTON 11/01/2001
110 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
2NDC:0169-3685-921 in 1 CARTON 11/01/2001
210 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
NovoLog Mix 70/30insulin aspart INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-3696
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:0169-3696-195 in 1 CARTON 09/11/2002
13 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0169-3696-971 in 1 CARTON 09/11/2002
23 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0169-3696-981 in 1 CARTON 09/11/2002
3NDC:0169-3696-903 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
NovoLog Mix 70/30insulin aspart INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-2200
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:0169-2200-111 in 1 CARTON 07/01/2021
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
NovoLog Mix 70/30insulin aspart INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-2201
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:0169-2201-255 in 1 CARTON 07/01/2021
13 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(622920320)

PRINCIPAL DISPLAY PANEL

NDC 0169-3685-12

List 368512

NovoLog® Mix 70/30

(insulin aspart protamine and

insulin aspart) injectable suspension

100 units/mL (U-100)

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

NovoLog Mix 70/30 vial carton

PRINCIPAL DISPLAY PANEL

NDC 0169-2200-11

List 220011

NovoLog® Mix 70/30

(insulin aspart protamine

and insulin aspart) injectable suspension

100 units/mL (U-100)

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

ONLY FOR RETAIL SALE BY WALMART

AND ITS AFFILIATES

ReliOn ®

NovoLog Mix 70/30 ReliOn vial carton

PRINCIPAL DISPLAY PANEL

NDC 0169-3696-19

List 369619

NovoLog® Mix 70/30

FlexPen® Prefilled Pen

(insulin aspart protamine and

insulin aspart) injectable suspension

For Single Patient Use Only

100 units/mL (U-100)

5×3 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.

Rx only

Dispense in this sealed carton.

NLM 70-30 FlexPen - 8-9674-31-304-7

PRINCIPAL DISPLAY PANEL

NDC 0169-2201-25

List 220125

NovoLog® Mix 70/30

FlexPen® Prefilled Pen

(insulin aspart protamine and

insulin aspart) injectable suspension

For Single Patient Use Only

100 units/mL (U-100)

5×3 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.

Rx only

Dispense in this sealed carton.

ONLY FOR RETAIL SALE BY WALMART AND ITS AFFILIATES

ReliOn ®

FlexPen ReliOn - 8-9674-31-360-3