NDC Code(s) : 0169-7501-11, 0169-7501-90, 0169-3303-12, 0169-3303-91, 0169-3303-90, 0169-6339-10, 0169-6339-90, 0169-6339-97, 0169-6339-98, 0169-6338-10, 0169-6338-90, 0169-6338-98, 0169-2001-90, 0169-2100-11, 0169-2101-12, 0169-2101-25
Packager : Novo Nordisk

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NOVOLOGinsulin aspart INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-7501
Route of Administration INTRAVENOUS, 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
SODIUM CHLORIDE(UNII: 451W47IQ8X)0.58 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:0169-7501-111 in 1 CARTON 27/08/2001
110 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
2NDC:0169-7501-901 in 1 CARTON 27/08/2001
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 BLA020986 08/27/2001
NOVOLOGinsulin aspart INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-3303
Route of Administration INTRAVENOUS, 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
SODIUM CHLORIDE(UNII: 451W47IQ8X)0.58 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:0169-3303-125 in 1 CARTON 27/08/2001
13 mL in 1 CARTRIDGE Type 0: Not a Combination Product
2NDC:0169-3303-911 in 1 CARTON 27/08/2001
23 mL in 1 CARTRIDGE Type 0: Not a Combination Product
3NDC:0169-3303-905 in 1 CARTON 27/08/2001
33 mL in 1 CARTRIDGE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA020986 08/27/2001
NOVOLOGinsulin aspart INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-6339
Route of Administration INTRAVENOUS, 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
SODIUM CHLORIDE(UNII: 451W47IQ8X)0.58 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:0169-6339-105 in 1 CARTON 22/01/2003
13 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0169-6339-971 in 1 CARTON 22/01/2003
2NDC:0169-6339-903 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0169-6339-981 in 1 CARTON 22/01/2003
3NDC:0169-6339-903 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 BLA020986 01/22/2003
NOVOLOGinsulin aspart INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-6338
Route of Administration INTRAVENOUS, 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
SODIUM CHLORIDE(UNII: 451W47IQ8X)0.58 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:0169-6338-105 in 1 CARTON 31/10/2030
13 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0169-6338-981 in 1 CARTON 31/10/2030
2NDC:0169-6338-903 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 BLA020986 10/31/2013
Insulin Diluting Medium for NovoLogwater injection INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-2001
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER(UNII: 059QF0KO0R)
(WATER - UNII:059QF0KO0R) 		WATER1 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)
METACRESOL(UNII: GGO4Y809LO)1.5 mg in 1 mL
PHENOL(UNII: 339NCG44TV)0.65 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-2001-901 in 1 CARTON 08/01/2018
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 BLA020986 08/27/2001
NOVOLOGinsulin aspart INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-2100
Route of Administration INTRAVENOUS, 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
SODIUM CHLORIDE(UNII: 451W47IQ8X)0.58 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:0169-2100-111 in 1 CARTON 25/05/2021
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 BLA020986 08/27/2001
NOVOLOGinsulin aspart INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-2101
Route of Administration INTRAVENOUS, 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
SODIUM CHLORIDE(UNII: 451W47IQ8X)0.58 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:0169-2101-255 in 1 CARTON 25/05/2021
1NDC:0169-2101-123 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 BLA020986 01/22/2003

LABELER - Novo Nordisk(622920320)

PRINCIPAL DISPLAY PANEL

  •   NovoLog®NDC 0169-7501-11
  •  (insulin aspart) injection List 750111

100 units/mL (U-100)

For intravenous or subcutaneous use.

Rx only

Use only with a U-100 syringe.

10 mL multiple-dose vial

NovoLog Vial (NN) Carton - 8-0902-31-305-9

PRINCIPAL DISPLAY PANEL

NovoLog®

  •  (insulin aspart) injection
  •  

NDC 0169-2100-11

List 210011

100 units/mL (U-100)

For intravenous or subcutaneous use.

Rx only

Use only with a U-100 syringe.

10 mL multiple-dose vial

ONLY FOR RETAIL SALE BY WALMART AND ITS AFFILIATES

Relion

Vial ReliOn - 8-0902-31-360-1

PRINCIPAL DISPLAY PANEL

NDC 0169-3303-12 List 330312

NovoLog®

PenFill®

(insulin aspart) injection

For Single Patient Use Only

100 units/mL (U-100)

For subcutaneous use

For use with Novo Nordisk 3 mL PenFill® cartridge compatible delivery devices and NovoFine® 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 28 days. Avoid freezing. Protect from light.

3 mL cartridges

5 cartridges per package

Rx only

NovoLog PenFill - 8-0905-31-304-6

PRINCIPAL DISPLAY PANEL

NDC 0169-6339-10 List 633910

NovoLog® FlexPen®

Prefilled Pen

(insulin aspart) injection

For Single Patient Use Only

100 units/mL (U-100)

5 x 3 mL prefilled pens

For subcutaneous use.

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 28 days. Avoid freezing. Protect from light.

Rx only

Dispense in this sealed carton.

FlexPen NN Brand 8-9670-31-304-8

PRINCIPAL DISPLAY PANEL

NDC 0169-2101-25

List 210125

NovoLog® FlexPen®

Prefilled pen

(insulin aspart) injection

For Single Patient Use Only

100 units/mL (U-100)

5×3 mL prefilled pens

For subcutaneous use.

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 28 days. Avoid freezing. Protect from light.

Rx only

Dispense in this sealed carton.

ONLY FOR RETAIL SALES BY WALMART AND ITS AFFILIATES

ReliOn

FlexPen ReliOn 8-9670-31-360-3

PRINCIPAL DISPLAY PANEL

NDC 0169-6338-10 List 633810

NovoLog® FlexTouch®

(insulin aspart) injection

For Single Patient Use Only

100 units/mL (U-100)

5 x 3 mL Prefilled Pens

For subcutaneous use only

Recommended for use with

NovoFine®, NovoFine® Plusor 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 28 days. Avoid freezing. Protect from light.

Rx only

Dispense in this sealed carton.

NovoLog FlexTouch - 8-9500-31-301-6

PRINCIPAL DISPLAY PANEL

List: 200190 NDC 0169-2001-90

Insulin Diluting Medium

for NovoLog®

10 mL multiple-dose vial

Use only with NovoLog®

This product does not contain insulin.

Insulin Diluting Medium Carton - 8-0909-31-306-2