Prescription Drug Information: WEGOVY (Page 9 of 9)

wegovy 1 mg

NDC 0169-4501 -14 List 450114

1 mg

wegovy™

(semaglutide) injection

1 mg/0.5 mL

Use Wegovy 1 time a week

4 Single-Dose Prefilled Pens

Each pen delivers a single dose of 1 mg semaglutide

For subcutaneous use only

Single-Dose only

Rx only

Contains: 4 Wegovy pens, Product Literature.

Dispense the enclosed Medication Guide to each patient.

1 mg
(click image for full-size original)

wegovy 1.7 mg

NDC 0169-4517 -14 List 451714

1.7 mg

wegovy™

(semaglutide) injection

1.7 mg/0.75 mL

Use Wegovy 1 time a week

4 Single-Dose Prefilled Pens

Each pen delivers a single dose of 1.7 mg semaglutide

For subcutaneous use only

Single-Dose only

Rx only

Contains: 4 Wegovy pens, Product Literature.

Dispense the enclosed Medication Guide to each patient.

1.7 mg
(click image for full-size original)

wegovy 2.4 mg

NDC 0169-4524 -14 List 452414

2.4 mg

wegovy™

(semaglutide) injection

2.4 mg/0.75 mL

Use Wegovy 1 time a week

4 Single-Dose Prefilled Pens

Each pen delivers a single dose of 2.4 mg semaglutide

For subcutaneous use only

Single-Dose only

Rx only

Contains: 4 Wegovy pens, Product Literature.

Dispense the enclosed Medication Guide to each patient.

2.4 mg
(click image for full-size original)
WEGOVY semaglutide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-4525
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEMAGLUTIDE (SEMAGLUTIDE) SEMAGLUTIDE 0.25 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 1.42 mg in 0.5 mL
SODIUM CHLORIDE 8.25 mg in 0.5 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0169-4525-14 4 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC (0169-4525-01)
1 NDC:0169-4525-01 0.5 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (0169-4525-14)
2 NDC:0169-4525-94 4 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC (0169-4525-90)
2 NDC:0169-4525-90 0.5 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (0169-4525-94)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA215256 06/05/2021
WEGOVY semaglutide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-4505
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEMAGLUTIDE (SEMAGLUTIDE) SEMAGLUTIDE 0.5 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 1.42 mg in 0.5 mL
SODIUM CHLORIDE 8.25 mg in 0.5 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0169-4505-14 4 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC (0169-4505-01)
1 NDC:0169-4505-01 0.5 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (0169-4505-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA215256 06/05/2021
WEGOVY semaglutide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-4501
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEMAGLUTIDE (SEMAGLUTIDE) SEMAGLUTIDE 1.0 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 1.42 mg in 0.5 mL
SODIUM CHLORIDE 8.25 mg in 0.5 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0169-4501-14 4 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC (0169-4501-01)
1 NDC:0169-4501-01 0.5 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (0169-4501-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA215256 06/05/2021
WEGOVY semaglutide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-4517
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEMAGLUTIDE (SEMAGLUTIDE) SEMAGLUTIDE 1.7 mg in 0.75 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 1.42 mg in 0.75 mL
SODIUM CHLORIDE 8.25 mg in 0.75 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0169-4517-14 4 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC (0169-4517-01)
1 NDC:0169-4517-01 0.5 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (0169-4517-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA215256 06/05/2021
WEGOVY semaglutide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-4524
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEMAGLUTIDE (SEMAGLUTIDE) SEMAGLUTIDE 2.4 mg in 0.75 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 1.42 mg in 0.75 mL
SODIUM CHLORIDE 8.25 mg in 0.75 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0169-4524-14 4 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC (0169-4524-01)
1 NDC:0169-4524-01 0.5 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (0169-4524-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA215256 06/05/2021
Labeler — Novo Nordisk (622920320)
Establishment
Name Address ID/FEI Operations
Novo Nordisk A/S 305914798 MANUFACTURE (0169-4517), MANUFACTURE (0169-4524)
Establishment
Name Address ID/FEI Operations
Catalent Belgium SA 370696762 MANUFACTURE (0169-4525), MANUFACTURE (0169-4505), MANUFACTURE (0169-4501)
Establishment
Name Address ID/FEI Operations
Novo Nordisk Pharmaceutical Industries, LP 622920320 MANUFACTURE (0169-4525), MANUFACTURE (0169-4505), MANUFACTURE (0169-4501), MANUFACTURE (0169-4517), MANUFACTURE (0169-4524)

Revised: 06/2021 Novo Nordisk

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