FDA.reportPublic FDA data

Skyrizi

Product NDC
0074-5015
11-digit product format
000745015
Labeler code
0074
Product ID
0074-5015_9c9f7a2c-c686-4a89-b15d-cfd58ea603d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risankizumab-rzaa
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
AbbVie Inc.
Application
BLA761262
Marketing category
BLA
Marketing start
2022-06-16
Substance
RISANKIZUMAB
Active strength
600 mg/10mL
Pharmacologic classes
Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Skyrizi
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISANKIZUMAB600 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii90ZX3Q3FR7
Rxcui797544, 2166136, 2166137, 2166142, 2166143, 2540692, 2540695, 2540698, 2540699, 2604618, 2604622, 2604625, 2604628, 2613758, 2613759, 2632994, 2632997, 2632999, 2633000, 2633001

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
47a46f9e-58f7-4803-b9d3-2d36444a6c49Product name320250122
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-5015-01Skyrizi1 in 1 CARTONINJECTION1173
0074-5015-01Skyrizi10 mL in 1 VIAL, SINGLE-DOSEINJECTION10173
0074-5015-02Skyrizi10 mL in 1 VIAL, SINGLE-DOSEINJECTION10173
0074-5015-02Skyrizi1 in 1 CARTONINJECTION1173

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-5015-01ML - Milliliter0074-5015241ff588-f9ab-4a06-9a22-447427ac7b0a12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-5015SKYRIZI (RISANKIZUMAB-RZAA) KIT SKYRIZI (RISANKIZUMAB-RZAA) INJECTION [ABBVIE INC.]162Current NDC, Legacy NDC, 4 package rows20250515_7148c8eb-b39e-e20a-6494-a6df82392858.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2166143{2 (0.83 ML risankizumab-rzaa 90.4 MG/ML Prefilled Syringe [Skyrizi]) } Pack [Skyrizi 150 MG Dose Syringe Pack]BPCK7148c8eb-b39e-e20a-6494-a6df82392858173
2633000{2 (1 ML risankizumab-rzaa 90 MG/ML Prefilled Syringe [Skyrizi]) } Pack [Skyrizi 180 MG Dose Syringe Pack]BPCK7148c8eb-b39e-e20a-6494-a6df82392858173
2633002{4 (1 ML risankizumab-rzaa 90 MG/ML Prefilled Syringe [Skyrizi]) } Pack [Skyrizi 360 MG Dose Syringe Pack]BPCK7148c8eb-b39e-e20a-6494-a6df82392858173
2166137{2 (0.83 ML risankizumab-rzaa 90.4 MG/ML Prefilled Syringe) } PackGPCK7148c8eb-b39e-e20a-6494-a6df82392858173
2632999{2 (1 ML risankizumab-rzaa 90 MG/ML Prefilled Syringe) } PackGPCK7148c8eb-b39e-e20a-6494-a6df82392858173
2633001{4 (1 ML risankizumab-rzaa 90 MG/ML Prefilled Syringe) } PackGPCK7148c8eb-b39e-e20a-6494-a6df82392858173
797544isopropyl alcohol 70 % Medicated PadPSN7148c8eb-b39e-e20a-6494-a6df82392858173
2540692risankizumab-rzaa 150 MG in 1 mL Auto-InjectorPSN7148c8eb-b39e-e20a-6494-a6df82392858173
2540698risankizumab-rzaa 150 MG in 1 mL Prefilled SyringePSN7148c8eb-b39e-e20a-6494-a6df82392858173
2613758risankizumab-rzaa 180 MG in 1.2 ML CartridgePSN7148c8eb-b39e-e20a-6494-a6df82392858173
2723331risankizumab-rzaa 180 MG in 1.2 ML Prefilled SyringePSN7148c8eb-b39e-e20a-6494-a6df82392858173
2604625risankizumab-rzaa 360 MG in 2.4 ML CartridgePSN7148c8eb-b39e-e20a-6494-a6df82392858173
2604618risankizumab-rzaa 600 MG in 10 ML InjectionPSN7148c8eb-b39e-e20a-6494-a6df82392858173
2166137risankizumab-rzaa 75 MG in 0.83 mL (2) Prefilled Syringe PackPSN7148c8eb-b39e-e20a-6494-a6df82392858173
2166136risankizumab-rzaa 75 MG in 0.83 mL Prefilled SyringePSN7148c8eb-b39e-e20a-6494-a6df82392858173
2632994risankizumab-rzaa 90 MG in 1 ML Prefilled SyringePSN7148c8eb-b39e-e20a-6494-a6df82392858173
2632999risankizumab-rzaa 90 MG/1 ML X 2 (180 MG) Dose Prefilled Syringe PackPSN7148c8eb-b39e-e20a-6494-a6df82392858173
2633001risankizumab-rzaa 90 MG/1 ML X 4 (360 MG) Dose Prefilled Syringe PackPSN7148c8eb-b39e-e20a-6494-a6df82392858173
2540695Skyrizi 150 MG in 1 mL Auto-InjectorPSN7148c8eb-b39e-e20a-6494-a6df82392858173
2540699Skyrizi 150 MG in 1 mL Prefilled SyringePSN7148c8eb-b39e-e20a-6494-a6df82392858173
2613759Skyrizi 180 MG in 1.2 ML CartridgePSN7148c8eb-b39e-e20a-6494-a6df82392858173
2723332Skyrizi 180 MG in 1.2 ML Prefilled SyringePSN7148c8eb-b39e-e20a-6494-a6df82392858173
2604628Skyrizi 360 MG in 2.4 ML CartridgePSN7148c8eb-b39e-e20a-6494-a6df82392858173
2604622Skyrizi 600 MG in 10 ML InjectionPSN7148c8eb-b39e-e20a-6494-a6df82392858173
2166142Skyrizi 75 MG in 0.83 mL Prefilled SyringePSN7148c8eb-b39e-e20a-6494-a6df82392858173
2166143Skyrizi 75 MG/83 mL X 2 (150 MG) Dose Prefilled Syringe PackPSN7148c8eb-b39e-e20a-6494-a6df82392858173
2632997Skyrizi 90 MG in 1 ML Prefilled SyringePSN7148c8eb-b39e-e20a-6494-a6df82392858173
2633000Skyrizi 90 MG/1 ML X 2 (180 MG) Dose Prefilled Syringe PackPSN7148c8eb-b39e-e20a-6494-a6df82392858173
2633002Skyrizi 90 MG/1 ML X 4 (360 MG) Dose Prefilled Syringe PackPSN7148c8eb-b39e-e20a-6494-a6df82392858173
21661420.83 ML risankizumab-rzaa 90.4 MG/ML Prefilled Syringe [Skyrizi]SBD7148c8eb-b39e-e20a-6494-a6df82392858173
25406951 ML risankizumab-rzaa 150 MG/ML Auto-Injector [Skyrizi]SBD7148c8eb-b39e-e20a-6494-a6df82392858173
25406991 ML risankizumab-rzaa 150 MG/ML Prefilled Syringe [Skyrizi]SBD7148c8eb-b39e-e20a-6494-a6df82392858173
26329971 ML risankizumab-rzaa 90 MG/ML Prefilled Syringe [Skyrizi]SBD7148c8eb-b39e-e20a-6494-a6df82392858173
26137591.2 ML risankizumab-rzaa 150 MG/ML Cartridge [Skyrizi]SBD7148c8eb-b39e-e20a-6494-a6df82392858173
27233321.2 ML risankizumab-rzaa 150 MG/ML Prefilled Syringe [Skyrizi]SBD7148c8eb-b39e-e20a-6494-a6df82392858173
260462210 ML risankizumab-rzaa 60 MG/ML Injection [Skyrizi]SBD7148c8eb-b39e-e20a-6494-a6df82392858173
26046282.4 ML risankizumab-rzaa 150 MG/ML Cartridge [Skyrizi]SBD7148c8eb-b39e-e20a-6494-a6df82392858173
21661360.83 ML risankizumab-rzaa 90.4 MG/ML Prefilled SyringeSCD7148c8eb-b39e-e20a-6494-a6df82392858173
25406921 ML risankizumab-rzaa 150 MG/ML Auto-InjectorSCD7148c8eb-b39e-e20a-6494-a6df82392858173
25406981 ML risankizumab-rzaa 150 MG/ML Prefilled SyringeSCD7148c8eb-b39e-e20a-6494-a6df82392858173
26329941 ML risankizumab-rzaa 90 MG/ML Prefilled SyringeSCD7148c8eb-b39e-e20a-6494-a6df82392858173
26137581.2 ML risankizumab-rzaa 150 MG/ML CartridgeSCD7148c8eb-b39e-e20a-6494-a6df82392858173
27233311.2 ML risankizumab-rzaa 150 MG/ML Prefilled SyringeSCD7148c8eb-b39e-e20a-6494-a6df82392858173
260461810 ML risankizumab-rzaa 60 MG/ML InjectionSCD7148c8eb-b39e-e20a-6494-a6df82392858173
26046252.4 ML risankizumab-rzaa 150 MG/ML CartridgeSCD7148c8eb-b39e-e20a-6494-a6df82392858173
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD7148c8eb-b39e-e20a-6494-a6df82392858173
2166137{2 (risankizumab-rzaa 75 MG per 0.83 ML Prefilled Syringe) } PackSY7148c8eb-b39e-e20a-6494-a6df82392858173
21661420.83 ML Skyrizi 90.4 MG/ML Prefilled SyringeSY7148c8eb-b39e-e20a-6494-a6df82392858173
26329971 ML Skyrizi 90 MG/ML Prefilled SyringeSY7148c8eb-b39e-e20a-6494-a6df82392858173
26137591.2 ML Skyrizi 150 MG/ML CartridgeSY7148c8eb-b39e-e20a-6494-a6df82392858173
260462210 ML Skyrizi 60 MG/ML InjectionSY7148c8eb-b39e-e20a-6494-a6df82392858173
26046282.4 ML Skyrizi 150 MG/ML CartridgeSY7148c8eb-b39e-e20a-6494-a6df82392858173
797544isopropyl alcohol 70 % Medicated PadSY7148c8eb-b39e-e20a-6494-a6df82392858173
797544isopropyl alcohol 70 % Topical ClothSY7148c8eb-b39e-e20a-6494-a6df82392858173
797544isopropyl alcohol 70 % Topical SwabSY7148c8eb-b39e-e20a-6494-a6df82392858173
2540692risankizumab-rzaa 150 MG per 1 ML Auto-InjectorSY7148c8eb-b39e-e20a-6494-a6df82392858173
2540698risankizumab-rzaa 150 MG per 1 ML Prefilled SyringeSY7148c8eb-b39e-e20a-6494-a6df82392858173
2540692risankizumab-rzaa 150 MG/ML per 1 ML Auto-InjectorSY7148c8eb-b39e-e20a-6494-a6df82392858173
2540698risankizumab-rzaa 150 MG/ML per 1 ML Prefilled SyringeSY7148c8eb-b39e-e20a-6494-a6df82392858173
2613758risankizumab-rzaa 180 MG per 1.2 ML CartridgeSY7148c8eb-b39e-e20a-6494-a6df82392858173
2723331risankizumab-rzaa 180 MG per 1.2 ML Prefilled SyringeSY7148c8eb-b39e-e20a-6494-a6df82392858173
2604625risankizumab-rzaa 360 MG per 2.4 ML CartridgeSY7148c8eb-b39e-e20a-6494-a6df82392858173
2604618risankizumab-rzaa 600 MG per 10 ML InjectionSY7148c8eb-b39e-e20a-6494-a6df82392858173
2166136risankizumab-rzaa 75 MG per 0.83 ML Prefilled SyringeSY7148c8eb-b39e-e20a-6494-a6df82392858173
2632994risankizumab-rzaa 90 MG per 1 ML Prefilled SyringeSY7148c8eb-b39e-e20a-6494-a6df82392858173
2632999risankizumab-rzaa 90 MG/1 ML X 2 (180 MG) Dose Prefilled Syringe PackSY7148c8eb-b39e-e20a-6494-a6df82392858173
2633001risankizumab-rzaa 90 MG/1 ML X 4 (360 MG) Dose Prefilled Syringe PackSY7148c8eb-b39e-e20a-6494-a6df82392858173
2540695Skyrizi 150 MG per 1 ML Auto-InjectorSY7148c8eb-b39e-e20a-6494-a6df82392858173
2540699Skyrizi 150 MG per 1 ML Prefilled SyringeSY7148c8eb-b39e-e20a-6494-a6df82392858173
2540695Skyrizi 150 MG/ML per 1 ML Auto-InjectorSY7148c8eb-b39e-e20a-6494-a6df82392858173
2540699Skyrizi 150 MG/ML per 1 ML Prefilled SyringeSY7148c8eb-b39e-e20a-6494-a6df82392858173
2613759Skyrizi 180 MG per 1.2 ML CartridgeSY7148c8eb-b39e-e20a-6494-a6df82392858173
2723332Skyrizi 180 MG per 1.2 ML Prefilled SyringeSY7148c8eb-b39e-e20a-6494-a6df82392858173
2604628Skyrizi 360 MG per 2.4 ML CartridgeSY7148c8eb-b39e-e20a-6494-a6df82392858173
2604622Skyrizi 600 MG per 10 ML InjectionSY7148c8eb-b39e-e20a-6494-a6df82392858173
2166142Skyrizi 75 MG per 0.83 ML Prefilled SyringeSY7148c8eb-b39e-e20a-6494-a6df82392858173
2166143Skyrizi 75 MG/83 ML X 2 (150 MG) Dose Prefilled Syringe PackSY7148c8eb-b39e-e20a-6494-a6df82392858173
2632997Skyrizi 90 MG per 1 ML Prefilled SyringeSY7148c8eb-b39e-e20a-6494-a6df82392858173
2633000Skyrizi 90 MG/1 ML X 2 (180 MG) Dose Prefilled Syringe PackSY7148c8eb-b39e-e20a-6494-a6df82392858173
2633002Skyrizi 90 MG/1 ML X 4 (360 MG) Dose Prefilled Syringe PackSY7148c8eb-b39e-e20a-6494-a6df82392858173

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0074-5015-01000745015011 VIAL, SINGLE-DOSE in 1 CARTON (0074-5015-01) / 10 mL in 1 VIAL, SINGLE-DOSE2022-06-160000-00-00NoNoCurrent
0074-5015-02000745015021 VIAL, SINGLE-DOSE in 1 CARTON (0074-5015-02) / 10 mL in 1 VIAL, SINGLE-DOSE2022-06-160000-00-00YesNoCurrent