FDA.reportPublic FDA data

Skyrizi

Product NDC
0074-7040
11-digit product format
000747040
Labeler code
0074
Product ID
0074-7040_9c9f7a2c-c686-4a89-b15d-cfd58ea603d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risankizumab-rzaa
Dosage form
KIT
Labeler
AbbVie Inc.
Application
BLA761105
Marketing category
BLA
Marketing start
2024-03-04
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SkyriziRISANKIZUMAB-RZAAAbbVie Inc.7148c8eb-b39e-e20a-6494-a6df823928582026-06-15Warnings, Adverse reactionsExact identifier
application number: BLA761105
ndc (product): 0074-7040

Additional Listing Data#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
90ZX3Q3FR7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 2 · 25 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
2166136Internal RxNorm lookup
2166137Internal RxNorm lookup
2166142Internal RxNorm lookup
2166143Internal RxNorm lookup
2540692Internal RxNorm lookup
2540695Internal RxNorm lookup
2540698Internal RxNorm lookup
2540699Internal RxNorm lookup
2604618Internal RxNorm lookup
2604622Internal RxNorm lookup
2604625Internal RxNorm lookup
2604628Internal RxNorm lookup
2613758Internal RxNorm lookup
2613759Internal RxNorm lookup
2632994Internal RxNorm lookup
2632997Internal RxNorm lookup
2632999Internal RxNorm lookup
2633000Internal RxNorm lookup
2633001Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7148c8eb-b39e-e20a-6494-a6df82392858Available on FDA.report

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
0074-7032-01Skyrizi1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION1 mL90 mg in 1mL173
0074-7040-02Skyrizi1 in 1 CARTONKIT1173
0074-7040-02Skyrizi2 in 1 CARTONKIT2173

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-7040SKYRIZI (RISANKIZUMAB-RZAA) KIT SKYRIZI (RISANKIZUMAB-RZAA) INJECTION [ABBVIE INC.]162Current NDC, 3 package rows20250515_7148c8eb-b39e-e20a-6494-a6df82392858.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761105Skyrizirisankizumab-rzaa351(a)Disc2026-06-01

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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
0074-7032-01000747032011 mL in 1 SYRINGE, GLASS1 mlHistorical
0074-7040-02000747040022 CARTON in 1 CARTON (0074-7040-02) / 1 KIT in 1 CARTON * 1 mL in 1 SYRINGE, GLASS (0074-7032-01) 2 carton2024-03-04NoNoCurrent