FDA.reportPublic FDA data

ustekinumab-ttwe 45 MG per 0.5 ML Prefilled Syringe

RxCUI
2705568
RxNorm name
ustekinumab-ttwe 45 MG per 0.5 ML Prefilled Syringe
Display name
ustekinumab-ttwe 45 MG per 0.5 ML Prefilled Syringe
Full name
ustekinumab-ttwe 45 MG per 0.5 ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:26

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761373Pyzchivaustekinumab-ttwe351(k) InterchangeableRx2026-07-01
761425Pyzchivaustekinumab-ttwe351(k) InterchangeableRx2026-07-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PYZCHIVAUSTEKINUMAB-TTWESANDOZ INCe8a14922-7902-4d9f-8ba5-d91dccffed292026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 2705568
PYZCHIVAUSTEKINUMAB-TTWECordavis Limitedf356501d-1347-4557-a252-c2d9f1b2dcb22026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 2705568
USTEKINUMAB-TTWEUSTEKINUMAB-TTWEQuallent Pharmaceuticals Health LLC2b34392a-ecf6-41bd-8706-d4e9f0b25da82026-01-12Warnings, Adverse reactionsExact identifier
rxcui: 2705568

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
e8a14922-7902-4d9f-8ba5-d91dccffed29ustekinumab-ttwe 45 MG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML ustekinumab-ttwe 90 MG/ML Prefilled Syringe [SCD] · ustekinumab-ttwe 45 MG per 0.5 ML Prefilled Syringe [SY]316These highlights do not include all the information needed to use PYZCHIVA safely and effectively. See full prescribing information for PYZCHIVA. PYZCHIVA ® (ustekinumab-ttwe) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 PYZCHIVA (ustekinumab-ttwe) is biosimilar* to STELARA (ustekinumab).20260313
f356501d-1347-4557-a252-c2d9f1b2dcb2ustekinumab-ttwe 45 MG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML ustekinumab-ttwe 90 MG/ML Prefilled Syringe [SCD] · ustekinumab-ttwe 45 MG per 0.5 ML Prefilled Syringe [SY]36These highlights do not include all the information needed to use PYZCHIVA safely and effectively. See full prescribing information for PYZCHIVA. PYZCHIVA ® (ustekinumab-ttwe) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 PYZCHIVA (ustekinumab-ttwe) is biosimilar* to STELARA (ustekinumab).20260206
2b34392a-ecf6-41bd-8706-d4e9f0b25da8ustekinumab-ttwe 45 MG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML ustekinumab-ttwe 90 MG/ML Prefilled Syringe [SCD] · ustekinumab-ttwe 45 MG per 0.5 ML Prefilled Syringe [SY]36These highlights do not include all the information needed to use USTEKINUMAB-TTWE safely and effectively. See full prescribing information for USTEKINUMAB-TTWE. USTEKINUMAB-TTWE injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 Ustekinumab-ttwe is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful dif20260112