FDA.reportPublic FDA data

WEZLANA

Product NDC
84612-076
11-digit product format
846120076
Labeler code
84612
Product ID
84612-076_bc6353b9-cffb-4c14-b71e-0155a5294799
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab-auub
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Nuvaila Limited
Application
BLA761285
Marketing category
BLA
Marketing start
2025-01-01
Substance
USTEKINUMAB
Active strength
45 mg/.5mL
Pharmacologic classes
Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], 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
WEZLANA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
USTEKINUMAB45 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FU77B4U5Z0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2700669Internal RxNorm lookup
2700676Internal RxNorm lookup
2700679Internal RxNorm lookup
2700682Internal RxNorm lookup
2700685Internal RxNorm lookup
2700689Internal RxNorm lookup
2700691Internal RxNorm lookup
2700692Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6c23978-09f0-4796-88f7-d0ce7e3ed04eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9101c6a6-2dd0-4586-9db6-ccb20dc679c9Product name220171206
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84612-076-01WEZLANA1 in 1 CARTONINJECTION, SOLUTION18
84612-076-01WEZLANA0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84612-076-01ML - Milliliter84612-0766fcb6025-6852-4b68-9769-4572ed85c7bd12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84612-076WEZLANA (USTEKINUMAB-AUUB) INJECTION, SOLUTION [OPTUM HEALTH SOLUTIONS (IRELAND) LIMITED]2Current NDC, 2 package rows20250403_a6c23978-09f0-4796-88f7-d0ce7e3ed04e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WEZLANAUSTEKINUMAB-AUUBNuvaila Limiteda6c23978-09f0-4796-88f7-d0ce7e3ed04e2026-06-03Warnings, Adverse reactionsExact identifier
application number: BLA761285
ndc (product): 84612-076

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761285Wezlanaustekinumab-auub351(k) InterchangeableRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2700669ustekinumab-auub 130 MG in 26 ML InjectionPSNa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700679ustekinumab-auub 45 MG in 0.5 ML InjectionPSNa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700685ustekinumab-auub 45 MG in 0.5 ML Prefilled SyringePSNa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700691ustekinumab-auub 90 MG in 1 ML Prefilled SyringePSNa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700676WEZLANA 130 MG in 26 ML InjectionPSNa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700682WEZLANA 45 MG in 0.5 ML InjectionPSNa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700689WEZLANA 45 MG in 0.5 ML Prefilled SyringePSNa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700692WEZLANA 90 MG in 1 ML Prefilled SyringePSNa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
27006820.5 ML ustekinumab-auub 90 MG/ML Injection [Wezlana]SBDa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
27006890.5 ML ustekinumab-auub 90 MG/ML Prefilled Syringe [Wezlana]SBDa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
27006921 ML ustekinumab-auub 90 MG/ML Prefilled Syringe [Wezlana]SBDa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
270067626 ML ustekinumab-auub 5 MG/ML Injection [Wezlana]SBDa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
27006790.5 ML ustekinumab-auub 90 MG/ML InjectionSCDa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
27006850.5 ML ustekinumab-auub 90 MG/ML Prefilled SyringeSCDa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
27006911 ML ustekinumab-auub 90 MG/ML Prefilled SyringeSCDa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
270066926 ML ustekinumab-auub 5 MG/ML InjectionSCDa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700669ustekinumab-auub 130 MG per 26 ML InjectionSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700679ustekinumab-auub 45 MG per 0.5 ML InjectionSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700685ustekinumab-auub 45 MG per 0.5 ML Prefilled SyringeSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700669ustekinumab-auub 5 MG/ML per 26 ML InjectionSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700691ustekinumab-auub 90 MG per 1 ML Prefilled SyringeSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700679ustekinumab-auub 90 MG/ML per 0.5 ML InjectionSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700685ustekinumab-auub 90 MG/ML per 0.5 ML Prefilled SyringeSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700691ustekinumab-auub 90 MG/ML per 1 ML Prefilled SyringeSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700676Wezlana 130 MG per 26 ML InjectionSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700682Wezlana 45 MG per 0.5 ML InjectionSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700689Wezlana 45 MG per 0.5 ML Prefilled SyringeSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700676Wezlana 5 MG/ML per 26 ML InjectionSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700692Wezlana 90 MG per 1 ML Prefilled SyringeSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700682Wezlana 90 MG/ML per 0.5 ML InjectionSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700689Wezlana 90 MG/ML per 0.5 ML Prefilled SyringeSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8
2700692Wezlana 90 MG/ML per 1 ML Prefilled SyringeSYa6c23978-09f0-4796-88f7-d0ce7e3ed04e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84612-076-01846120076011 SYRINGE in 1 CARTON (84612-076-01) / .5 mL in 1 SYRINGE1 syringe2025-01-01NoNoCurrent