Skyrizi (Page 13 of 13)

NDC 0074-7034-02

2 x 1 mL Prefilled Syringes

Skyriz i ^®

risankizumab-rzaa Injection

90 mg/mL per syringe

2 x 90 mg/mL. Single-Dose Prefilled

Syringes for a total 180 mg/2 mL dose

FOR SUBCUTANEOUS USE ONLY

FOR HEALTHCARE PROVIDER ADMINISTRATION ONLY

www. SKYRIZI.com

Rx Only

abbvie

NDC 0074-7032-90

One 1 mL Single-Dose Prefilled Syringe

Skyriz i ^®

risankizumab-rzaa Injection

90 mg/mL

FOR SUBCUTANEOUS USE ONLY

FOR HEALTHCARE PROVIDER ADMINISTRATION ONLY

www. SKYRIZI.com

Rx Only

abbvie

NDC 0074-7036-04

4 x 1 mL Prefilled Syringes

Skyriz i ^®

risankizumab-rzaa Injection

90 mg/mL per syringe

4 x 90 mg/mL Single-Dose Prefilled

Syringes for a total 360 mg/4 mL dose

FOR SUBCUTANEOUS USE ONLY

FOR HEALTHCARE PROVIDER ADMINISTRATION ONLY

ATTENTION PHARMACIST:

Each patient is required to receive the enclosed Medication Guide.

The entire carton is to be dispensed as a unit.

Return to Pharmacy if carton seal is broken or missing.

www. SKYRIZI.com

Rx Only

abbvie

NDC 0074-7032-01

Skyrizi®

Risankizumab-rzaa

Injection

90 mg/mL

For Subcutaneous Use Only

Rx Only

SKYRIZI risankizumab-rzaa kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-2042

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0074-2042-02 1 KIT in 1 CARTON None 2 NDC:0074-2042-71 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 SYRINGE 1.66 mL Part 2 2 PACKET 2 mL

Part 1 of 2 SKYRIZI risankizumab-rzaa injection, solution

Product Information Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RISANKIZUMAB (RISANKIZUMAB) RISANKIZUMAB 75 mg in 0.83 mL

Inactive Ingredients Ingredient Name Strength SUCCINIC ACID 0.049 mg in 0.83 mL SORBITOL 34 mg in 0.83 mL POLYSORBATE 20 0.17 mg in 0.83 mL WATER SODIUM SUCCINATE ANHYDROUS 0.53 mg in 0.83 mL

Packaging # Item Code Package Description Multilevel Packaging 1 0.83 mL in 1 SYRINGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761105 04/23/2019

Part 2 of 2 ALCOHOL SWAB isopropyl alcohol swab

Product Information Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.70 mL in 1 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 1 mL in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/23/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761105 04/23/2019 01/31/2023

SKYRIZI risankizumab-rzaa injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-1050 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RISANKIZUMAB (RISANKIZUMAB) RISANKIZUMAB 150 mg in 1 mL

Inactive Ingredients Ingredient Name Strength ACETIC ACID 0.054 mg in 1 mL POLYSORBATE 20 0.2 mg in 1 mL SODIUM ACETATE 0.75 mg in 1 mL TREHALOSE 63.33 mg in 1 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0074-1050-70 1 SYRINGE in 1 CARTON contains a SYRINGE 1 1 mL in 1 SYRINGE This package is contained within the CARTON (0074-1050-70) 2 NDC:0074-1050-01 1 SYRINGE in 1 CARTON contains a SYRINGE 2 1 mL in 1 SYRINGE This package is contained within the CARTON (0074-1050-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761105 04/26/2021

SKYRIZI risankizumab-rzaa injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-2100 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RISANKIZUMAB (RISANKIZUMAB) RISANKIZUMAB 150 mg in 1 mL

Inactive Ingredients Ingredient Name Strength ACETIC ACID 0.054 mg in 1 mL POLYSORBATE 20 0.2 mg in 1 mL WATER TREHALOSE 63.33 mg in 1 mL SODIUM ACETATE 0.75 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0074-2100-70 1 SYRINGE in 1 CARTON contains a SYRINGE 1 1 mL in 1 SYRINGE This package is contained within the CARTON (0074-2100-70) 2 NDC:0074-2100-01 1 SYRINGE in 1 CARTON contains a SYRINGE 2 1 mL in 1 SYRINGE This package is contained within the CARTON (0074-2100-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761105 04/26/2021

SKYRIZI risankizumab-rzaa kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-1070

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0074-1070-01 1 KIT in 1 CARTON None 2 NDC:0074-1070-02 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CARTRIDGE 2.4 mL

Part 1 of 1 SKYRIZI risankizumab-rzaa injection, solution

Product Information Item Code (Source) NDC:0074-1069 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RISANKIZUMAB (RISANKIZUMAB) RISANKIZUMAB 360 mg in 2.4 mL

Inactive Ingredients Ingredient Name Strength ACETIC ACID 0.13 mg in 2.4 mL POLYSORBATE 20 0.48 mg in 2.4 mL SODIUM ACETATE 1.8 mg in 2.4 mL WATER TREHALOSE 152 mg in 2.4 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0074-1069-01 2.4 mL in 1 CARTRIDGE None 2 NDC:0074-1069-02 2.4 mL in 1 CARTRIDGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761105 06/16/2022

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761105 06/16/2022

SKYRIZI risankizumab-rzaa injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-5015 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RISANKIZUMAB (RISANKIZUMAB) RISANKIZUMAB 600 mg in 10 mL

Inactive Ingredients Ingredient Name Strength ACETIC ACID 0.54 mg in 10 mL POLYSORBATE 20 2 mg in 10 mL WATER TREHALOSE 633.3 mg in 10 mL SODIUM ACETATE 7.5 mg in 10 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0074-5015-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 1 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0074-5015-01) 2 NDC:0074-5015-02 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 2 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0074-5015-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761262 06/16/2022

SKYRIZI risankizumab-rzaa kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-1065

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0074-1065-01 1 KIT in 1 CARTON None 2 NDC:0074-1065-02 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CARTRIDGE 1.2 mL

Part 1 of 1 SKYRIZI risankizumab-rzaa injection, solution

Product Information Item Code (Source) NDC:0074-1066 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RISANKIZUMAB (RISANKIZUMAB) RISANKIZUMAB 180 mg in 1.2 mL

Inactive Ingredients Ingredient Name Strength ACETIC ACID 0.065 mg in 1.2 mL POLYSORBATE 20 0.24 mg in 1.2 mL SODIUM ACETATE 0.9 mg in 1.2 mL TREHALOSE 76 mg in 1.2 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0074-1066-01 1.2 mL in 1 CARTRIDGE None 2 NDC:0074-1066-02 1.2 mL in 1 CARTRIDGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761105 06/16/2022

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761105 09/23/2022

SKYRIZI risankizumab-rzaa kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-7034

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0074-7034-02 2 CARTON in 1 CARTON contains a CARTON 1 1 KIT in 1 CARTON This package is contained within the CARTON (0074-7034-02)

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 SYRINGE, GLASS 1 mL

Part 1 of 1 SKYRIZI risankizumab-rzaa injection, solution

Product Information Item Code (Source) NDC:0074-7032 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RISANKIZUMAB (RISANKIZUMAB) RISANKIZUMAB 90 mg in 1 mL

Inactive Ingredients Ingredient Name Strength POLYSORBATE 20 0.2 mg in 1 mL SODIUM SUCCINATE ANHYDROUS 0.63 mg in 1 mL SORBITOL 41 mg in 1 mL SUCCINIC ACID 0.059 mg in 1 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0074-7032-90 2 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS (0074-7032-01) 1 NDC:0074-7032-01 1 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (0074-7032-90)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761105 03/22/2023

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761105 03/22/2023

SKYRIZI risankizumab-rzaa kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-7036

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0074-7036-04 4 CARTON in 1 CARTON contains a CARTON 1 1 KIT in 1 CARTON This package is contained within the CARTON (0074-7036-04)

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 SYRINGE, GLASS 1 mL

Part 1 of 1 SKYRIZI risankizumab-rzaa injection, solution

Product Information Item Code (Source) NDC:0074-7032 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RISANKIZUMAB (RISANKIZUMAB) RISANKIZUMAB 90 mg in 1 mL

Inactive Ingredients Ingredient Name Strength POLYSORBATE 20 0.2 mg in 1 mL SODIUM SUCCINATE ANHYDROUS 0.63 mg in 1 mL SORBITOL 41 mg in 1 mL SUCCINIC ACID 0.059 mg in 1 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0074-7032-01 1 mL in 1 SYRINGE, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761105 03/22/2023

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761105 03/22/2023

Labeler — AbbVie Inc. (078458370)

Revised: 05/2023 AbbVie Inc.