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 Identifiers#

Field, Values table
FieldValues
UniiFU77B4U5Z0
Rxcui2700669, 2700676, 2700679, 2700682, 2700685, 2700689, 2700691, 2700692

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

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