Skyrizi (Page 13 of 13)

NDC 0074-2042-71

NOT FOR SALE

2 x 0.83 mL prefilled syringes

Skyrizi ®

risankizumab-rzaa Injection

75 mg/0.83 mL per Syringe

FOR SUBCUTANEOUS USE ONLY

FOR A 150 MG DOSE,
TWO 75 MG SYRINGES ARE REQUIRED,

INJECT ONE SYRINGE AFTER THE OTHER

ATTENTION PHYSICIAN: Dispense the enclosed Medication Guide to each patient.

The entire carton is to be dispensed as a unit.

Return to physician if carton perforations are broken.

www.SKYRIZI.com

Rx only

abbvie

NDC 0074-2042-71 
NOT FOR SALE
2 x 0.83 mL prefilled syringes
Skyrizii®
risankizumab-rzaa Injection 
75 mg/0.83 mL per Syringe
FOR SUBCUTANEOUS USE ONLY 
FOR A 150 MG DOSE,
TWO 75 MG SYRINGES ARE REQUIRED,
INJECT ONE SYRINGE AFTER THE OTHER
ATTENTION PHYSICIAN:
Dispense the enclosed Medication Guide to each patient.
The entire carton is to be dispensed as a unit. 
Return to physician if carton perforations are broken. 
www.SKYRIZI.com
Rx only
abbvie
(click image for full-size original)

NDC 0074-1070-01

1 x 2.4 mL P refilled Cartridge

Skyriz i ®

risankizumab-rzaa Injection

( 160 mg/ 2.4 mL )

150 mg/mL

FOR SUBCUTANEOUS USE ONLY

Single Dose

SKYRIZI.com

Rx only

abbvie

NDC 0074-1070-01 
1 x 2.4 mL Prefilled Cartridge
Skyrizi®
risankizumab-rzaa Injection 
(160 mg/2.4 mL)
150 mg/mL
FOR SUBCUTANEOUS USE ONLY 
Single Dose
SKYRIZI.com
Rx only
abbvie
(click image for full-size original)

NDC 0074-1070-02

NOT FOR SALE

1 x 2.4 mL P refilled Cartridge

1 On-Body Injector

Skyriz i ®

risankizumab-rzaa Injection

360 mg/ 2.4 mL

( 150 mg/mL )

FOR SUBCUTANEOUS USE ONLY

Single Dose

SKYRIZI.com

Rx only

abbvie

NDC 0074-1070-02 
NOT FOR SALE
1 x 2.4 mL Prefilled Cartridge
1 On-Body Injector
Skyrizi®
risankizumab-rzaa Injection 
360 mg/2.4 mL
(150 mg/mL)
FOR SUBCUTANEOUS USE ONLY 
Single Dose
SKYRIZI.com
Rx only
abbvie
(click image for full-size original)

NDC 0074-5015-01

Skyriz i ®

risankizumab-rzaa Injection

600 mg/ 10 mL

(60 mg/mL)

FOR INTR A VENOUS USE ONLY

Must be diluted prior to use

One 10 mL Single-Dose Vial-

Discard Unused Portion

Attention: Dispense the enclosed Medication Guide to each patient.

Rx only

abbvie

NDC 0074-5015-01 
Skyrizi®
risankizumab-rzaa Injection 
600 mg/10 mL
(60 mg/mL)
FOR INTRAVENOUS USE ONLY 
Must be diluted prior to use
One 10 mL Single-Dose Vial-
Discard Unused Portion
Attention: Dispense the enclosed Medication Guide to each patient.
Rx only
abbvie
(click image for full-size original)

NDC 0074-5015-02

Skyriz i ®

risankizumab-rzaa Injection

600 mg/ 10 mL

(60 mg/mL)

FOR INTR A VENOUS USE ONLY

Must be diluted prior to use

One 10 mL Single-Dose Vial-

Discard Unused Portion

NOT FOR SALE

Attention: Dispense the enclosed Medication Guide to each patient.

Rx only

abbvie

NDC 0074-5015-02
Skyrizi®
risankizumab-rzaa Injection 
600 mg/10 mL
(60 mg/mL)
FOR INTRAVENOUS USE ONLY 
Must be diluted prior to use
One 10 mL Single-Dose Vial-
Discard Unused Portion
NOT FOR SALE
Attention: Dispense the enclosed Medication Guide to each patient.
Rx only
abbvie
(click image for full-size original)

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 HEXAHYDRATE 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
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
POLYSORBATE 20
SODIUM ACETATE
TREHALOSE DIHYDRATE
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 DIHYDRATE 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
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 2 SYRINGE 1.66 mL
Part 1 of 1
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 150 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SUCCINIC ACID 0.13 mg in 1 mL
POLYSORBATE 20 0.48 mg in 1 mL
SODIUM SUCCINATE HEXAHYDRATE 1.8 mg in 1 mL
WATER
TREHALOSE 152 mg in 1 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 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 60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID 0.054 mg in 1 mL
POLYSORBATE 20 2 mg in 1 mL
WATER
TREHALOSE DIHYDRATE 633.3 mg in 1 mL
SODIUM ACETATE 7.5 mg in 1 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)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761262 06/16/2022
Labeler — AbbVie Inc. (078458370)

Revised: 06/2022 AbbVie Inc.

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