NDC Code(s) : 0169-4136-11, 0169-4136-02, 0169-4132-90, 0169-4132-97, 0169-4132-11, 0169-4132-12, 0169-4130-01, 0169-4130-13, 0169-4772-11, 0169-4772-12, 0169-4772-90, 0169-4772-97, 0169-4181-03, 0169-4181-13, 0169-4181-90, 0169-4181-97
Packager : Novo Nordisk

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ozempicsemaglutide INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-4136
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEMAGLUTIDE(UNII: 53AXN4NNHX)
(SEMAGLUTIDE - UNII:53AXN4NNHX) 		SEMAGLUTIDE1.34 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)1.42 mg in 1 mL
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)14.0 mg in 1 mL
PHENOL(UNII: 339NCG44TV)5.50 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-4136-022 in 1 CARTON 12/06/2017
1NDC:0169-4136-111.5 mL in 1 SYRINGE, PLASTIC Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209637 12/06/2017 10/31/2023
Ozempicsemaglutide INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-4132
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEMAGLUTIDE(UNII: 53AXN4NNHX)
(SEMAGLUTIDE - UNII:53AXN4NNHX) 		SEMAGLUTIDE1.34 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)1.42 mg in 1 mL
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)14.0 mg in 1 mL
PHENOL(UNII: 339NCG44TV)5.50 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-4132-971 in 1 CARTON 12/06/2017
1NDC:0169-4132-901.5 mL in 1 SYRINGE, PLASTIC Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:0169-4132-121 in 1 CARTON 12/06/2017
2NDC:0169-4132-111.5 mL in 1 SYRINGE, PLASTIC Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209637 12/06/2017 09/30/2025
Ozempicsemaglutide INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-4130
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEMAGLUTIDE(UNII: 53AXN4NNHX)
(SEMAGLUTIDE - UNII:53AXN4NNHX) 		SEMAGLUTIDE1.34 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)1.42 mg in 1 mL
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)14.0 mg in 1 mL
PHENOL(UNII: 339NCG44TV)5.50 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-4130-131 in 1 CARTON 01/03/2021
1NDC:0169-4130-013 mL in 1 SYRINGE, PLASTIC Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209637 09/30/2020
Ozempicsemaglutide INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-4772
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEMAGLUTIDE(UNII: 53AXN4NNHX)
(SEMAGLUTIDE - UNII:53AXN4NNHX) 		SEMAGLUTIDE2.68 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)1.42 mg in 1 mL
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)14.0 mg in 1 mL
PHENOL(UNII: 339NCG44TV)5.50 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-4772-121 in 1 CARTON 25/04/2022
1NDC:0169-4772-113 mL in 1 SYRINGE, PLASTIC Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:0169-4772-971 in 1 CARTON 25/04/2022
2NDC:0169-4772-903 mL in 1 SYRINGE, PLASTIC Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209637 04/25/2022
Ozempicsemaglutide INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-4181
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEMAGLUTIDE(UNII: 53AXN4NNHX)
(SEMAGLUTIDE - UNII:53AXN4NNHX) 		SEMAGLUTIDE0.68 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)1.42 mg in 1 mL
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)14.0 mg in 1 mL
PHENOL(UNII: 339NCG44TV)5.50 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-4181-131 in 1 CARTON 10/07/2022
1NDC:0169-4181-033 mL in 1 SYRINGE, PLASTIC Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:0169-4181-971 in 1 CARTON 10/07/2022
2NDC:0169-4181-903 mL in 1 SYRINGE, PLASTIC Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209637 10/07/2022

LABELER - Novo Nordisk(622920320)

Establishment
Name Address ID/FEI Business Operations
Novo Nordisk A/S 305914798 MANUFACTURE(0169-4136, 0169-4132, 0169-4130, 0169-4772, 0169-4181)

Establishment
Name Address ID/FEI Business Operations
Novo Nordisk Pharmaceutical Industries, LP 622920320 MANUFACTURE(0169-4136, 0169-4132, 0169-4130, 0169-4772, 0169-4181)

PRINCIPAL DISPLAY PANEL

0.25 mg

0.5 mg

NDC 0169-4181-13List 418113

OZEMPIC®

(semaglutide) injection

For Single Patient Use Only

2 mg/3 mL (0.68 mg/mL) Prefilled pen

Pen delivers doses in 0.25 mg or 0.5 mg increments only

For subcutaneous use only

Use OZEMPIC once weekly

Contains: 1 OZEMPIC pen, 6 NovoFine ® Plus 32G needles, Product Literature.

Dispense the enclosed Medication Guide to each patient.

image_155

PRINCIPAL DISPLAY PANEL

1 mg

NDC 0169-4130-13List 413013

OZEMPIC®

(semaglutide) injection

For Single Patient Use Only

4 mg/3 mL (1.34 mg/mL) Prefilled pen

Pen delivers doses in 1 mg increments only

For subcutaneous use only

Use OZEMPIC once weekly

Contains: 1 OZEMPIC pen, 4 NovoFine ® Plus 32G needles, Product Literature.

Dispense the enclosed Medication Guide to each patient.

image_153

PRINCIPAL DISPLAY PANEL

2 mg

NDC 0169-4772-12List 477212

OZEMPIC®

(semaglutide) injection

For Single Patient Use Only

8 mg/3 mL (2.68 mg/mL) Prefilled pen

Pen delivers 4 doses of 2 mg only

For subcutaneous use only

Use OZEMPIC once weekly

Contains: 1 OZEMPIC pen, 4 NovoFine ® Plus 32G needles, Product Literature.

Dispense the enclosed Medication Guide to each patient.

image_154

PRINCIPAL DISPLAY PANEL

0.25 mg

0.5 mg

NDC 0169-4132-12List 413212

OZEMPIC®

(semaglutide) injection

For Single Patient Use Only

2 mg/1.5 mL (1.34 mg/mL) Prefilled pen

Pen delivers doses in 0.25 mg or 0.5 mg increments only

For subcutaneous use only

Use OZEMPIC once weekly

Contains: 1 OZEMPIC pen, 6 NovoFine ® Plus 32G needles, Product Literature.

Dispense the enclosed Medication Guide to each patient.

1.5_mL_Carton

PRINCIPAL DISPLAY PANEL

1 mg

NDC 0169-4136-02List 413602

OZEMPIC®

(semaglutide) injection

For Single Patient Use Only

2 mg/1.5 mL (1.34 mg/mL) Prefilled pen

Pen delivers doses in 1 mg increments only

For subcutaneous use only

Use OZEMPIC once weekly

Contains: 2 OZEMPIC pens, 4 NovoFine ® Plus 32G needles, Product Literature.

Dispense the enclosed Medication Guide to each patient.

1_mg_-_1.5_ mL_Carton