FDA.reportPublic FDA data

ustekinumab-ttwe 45 MG in 0.5 ML Injection

RxCUI
2713885
RxNorm name
ustekinumab-ttwe 45 MG in 0.5 ML Injection
Display name
ustekinumab-ttwe 45 MG in 0.5 ML Injection
Full name
ustekinumab-ttwe 45 MG in 0.5 ML Injection
Term type
PSN
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 · 2 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: 2713885
USTEKINUMAB-TTWEUSTEKINUMAB-TTWEQuallent Pharmaceuticals Health LLC2b34392a-ecf6-41bd-8706-d4e9f0b25da82026-01-12Warnings, Adverse reactionsExact identifier
rxcui: 2713885

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
e8a14922-7902-4d9f-8ba5-d91dccffed29ustekinumab-ttwe 45 MG in 0.5 ML Injection [PSN] · 0.5 ML ustekinumab-ttwe 90 MG/ML Injection [SCD] · ustekinumab-ttwe 45 MG per 0.5 ML Injection [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
2b34392a-ecf6-41bd-8706-d4e9f0b25da8ustekinumab-ttwe 45 MG in 0.5 ML Injection [PSN] · 0.5 ML ustekinumab-ttwe 90 MG/ML Injection [SCD] · ustekinumab-ttwe 45 MG per 0.5 ML Injection [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