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NDC 0169-7501-90
API & Excipient Details

Insulin aspart marketed by Novo Nordisk under NDC Code 0169-7501-90

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
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
INSULIN ASPART(UNII: D933668QVX) (INSULIN ASPART - UNII:D933668QVX)	INSULIN ASPART	100 [iU] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0169-7501-11	1 in 1 CARTON	27/08/2001
1		10 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
2	NDC:0169-7501-90	1 in 1 CARTON	27/08/2001
2		10 mL in 1 VIAL, GLASS Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020986	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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
INSULIN ASPART(UNII: D933668QVX) (INSULIN ASPART - UNII:D933668QVX)	INSULIN ASPART	100 [iU] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0169-3303-12	5 in 1 CARTON	27/08/2001
1		3 mL in 1 CARTRIDGE Type 0: Not a Combination Product
2	NDC:0169-3303-91	1 in 1 CARTON	27/08/2001
2		3 mL in 1 CARTRIDGE Type 0: Not a Combination Product
3	NDC:0169-3303-90	5 in 1 CARTON	27/08/2001
3		3 mL in 1 CARTRIDGE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020986	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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
INSULIN ASPART(UNII: D933668QVX) (INSULIN ASPART - UNII:D933668QVX)	INSULIN ASPART	100 [iU] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0169-6339-10	5 in 1 CARTON	22/01/2003
1		3 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC:0169-6339-97	1 in 1 CARTON	22/01/2003
2	NDC:0169-6339-90	3 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC:0169-6339-98	1 in 1 CARTON	22/01/2003
3	NDC:0169-6339-90	3 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020986	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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
INSULIN ASPART(UNII: D933668QVX) (INSULIN ASPART - UNII:D933668QVX)	INSULIN ASPART	100 [iU] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0169-6338-10	5 in 1 CARTON	31/10/2030
1		3 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC:0169-6338-98	1 in 1 CARTON	31/10/2030
2	NDC:0169-6338-90	3 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020986	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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WATER(UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	1 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0169-2001-90	1 in 1 CARTON	08/01/2018
1		10 mL in 1 VIAL, GLASS Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020986	08/27/2001

LABELER - Novo Nordisk(622920320)

PRINCIPAL DISPLAY PANEL

NDC 0169-7501-11

List 750111

NovoLog^®

Insulin aspart Injection

10 mL 100 units/mL

Rx only

U-100

Image of NovoLog vial carton

PRINCIPAL DISPLAY PANEL

NDC 0169-3303-12 List 330312

NovoLog^®

PenFill^®

Insulin aspart Injection

For Single Patient Use Only

3 mL cartridges

100 units/mL (U-100)

5 cartridges per package

For use with Novo Nordisk 3 mL PenFill^® cartridge compatible delivery
devices, with or without the addition of a NovoPen^® 3 PenMate^®, and
NovoFine^® disposable needles.

Keep in a cold place.

Avoid freezing.

Protect from light.

Rx only

NovoLog PenFill carton.

PRINCIPAL DISPLAY PANEL

NDC 0169-6339-10 List 633910

NovoLog^® FlexPen^®

Prefilled Syringe

Insulin aspart Injection

For Single Patient Use Only

100 units/mL (U-100)

5 x 3 mL Prefilled Insulin Syringes

Rx only

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

Keep in a cold place.

Avoid freezing.

Protect from light.

Dispense in this sealed carton.

FlexPen

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

Rx Only

Recommended for use with
NovoFine^®, NovoFine Plus^® or
NovoTwist^® disposable needles.

Keep in a cold place until first use.

Store at 2° - 8°C (36° - 46°F).

Avoid freezing.

Protect from light.

Dispense in this sealed carton.

FlexTouch

PRINCIPAL DISPLAY PANEL

List: 200190 NDC 0169-2001-90

Insulin Diluting Medium for NovoLog®

10 mL

Use only with NovoLog®

Diluent Medium

Copyright © 2023 LePro PharmaCompass OPC Private Limited, All rights reserved.

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