NDC Code(s) : 73070-100-11, 73070-102-10, 73070-102-15, 73070-103-10, 73070-103-15
Packager : Novo Nordisk Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Insulin Aspartinsulin aspart INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73070-100
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:73070-100-111 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 BLA020986 08/27/2001
Insulin Aspartinsulin aspart INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73070-102
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:73070-102-155 in 1 CARTON 09/10/2019
1NDC:73070-102-103 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
Insulin Aspartinsulin aspart INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73070-103
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:73070-103-155 in 1 CARTON 09/10/2019
1NDC:73070-103-103 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 BLA020986 01/22/2003

LABELER - Novo Nordisk Pharma, Inc.(117032563)

PRINCIPAL DISPLAY PANEL

NDC 73070-100-11

List 010011

Insulin Aspart

injection

100 units/mL (U-100)

This product is NovoLog®.

For intravenous or subcutaneous use.

Rx only

Use only with a U-100 syringe.

10 mL multiple-dose vial

Vial Carton 8-0902-31-310-3

PRINCIPAL DISPLAY PANEL

NDC 73070-102-15 List 010215

Insulin Aspart

injection

PenFill®

For Single Patient Use Only

100 units/mL (U-100)

This product is NovoLog®.

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.

Rx only

3 mL cartridges

5 cartridges per package

Image of Insulin Aspart PenFill carton

PRINCIPAL DISPLAY PANEL

NDC 73070-103-15

List 010315

Insulin Aspart

injection

FlexPen® Prefilled Pen

For Single Patient Use Only

100 units/mL (U-100)

This product is NovoLog®.

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.

FlexPen 8-9670=31=310-4