NDC Code(s) : 0169-4060-13, 0169-4060-12, 0169-4060-90, 0169-4060-97, 0169-4060-98, 0169-4060-99
Packager : Novo Nordisk

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Victozaliraglutide INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-4060
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIRAGLUTIDE(UNII: 839I73S42A)
(LIRAGLUTIDE - UNII:839I73S42A) 		LIRAGLUTIDE6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL(UNII: 339NCG44TV)5.5 mg in 1 mL
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)14 mg in 1 mL
WATER(UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)1.42 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-4060-133 in 1 CARTON 25/01/2010
13 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0169-4060-122 in 1 CARTON 25/01/2010
23 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0169-4060-901 in 1 CARTON 25/01/2010
33 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4NDC:0169-4060-971 in 1 CARTON 15/10/2010
43 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
5NDC:0169-4060-981 in 1 CARTON 15/04/2013
53 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
6NDC:0169-4060-991 in 1 CARTON 13/02/2015
63 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
NDA NDA022341 01/25/2010

LABELER - Novo Nordisk(622920320)

Establishment
Name Address ID/FEI Business Operations
Novo Nordisk A/S 305914798 MANUFACTURE(0169-4060)

Establishment
Name Address ID/FEI Business Operations
Novo Nordisk Pharmaceutical Industries, LP 622920320 MANUFACTURE(0169-4060)

Establishment
Name Address ID/FEI Business Operations
Novo Nordisk A/S 305156788 API MANUFACTURE(0169-4060)

PRINCIPAL DISPLAY PANEL

NDC 0169-4060-13

List 406013

VICTOZA®

(liraglutide) injection

For Single Patient Use Only

18 mg/3 mL (6 mg/mL)

Each pen delivers doses of 0.6 mg, 1.2 mg or 1.8 mg

Subcutaneous use only

Discard pen 30 days after first use

REFRIGERATE - DO NOT FREEZE

Rx Only

Contains: 3 Victoza Pens, Product Literature

Dispense the enclosed Medication Guide to each patient

Intended for use with Novo Nordisk disposable needles

3 Pens

Carton image - 3 pens

PRINCIPAL DISPLAY PANEL

NDC 0169-4060-12

List 406012

VICTOZA®

(liraglutide) injection

For Single Patient Use Only

18 mg/3 mL (6 mg/mL)

Each pen delivers doses of 0.6 mg, 1.2 mg or 1.8 mg

Subcutaneous use only

Discard pen 30 days after first use

REFRIGERATE - DO NOT FREEZE

Rx Only

Contains: 2 Victoza Pens, Product Literature

Dispense the enclosed Medication Guide to each patient

Intended for use with Novo Nordisk disposable needles

2 Pens

Carton image - 2 pens