FDA.reportPublic FDA data

IMULDOSA 45 MG in 0.5 ML Prefilled Syringe

RxCUI
2717083
RxNorm name
IMULDOSA 45 MG in 0.5 ML Prefilled Syringe
Display name
IMULDOSA 45 MG in 0.5 ML Prefilled Syringe
Full name
IMULDOSA 45 MG in 0.5 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761364Imuldosaustekinumab-srlf351(k) InterchangeableRx2026-08-01

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IMULDOSAUSTEKINUMAB-SRLFAccord BioPharma Inc.2539a6cf-0fe5-1565-e063-6294a90a36182026-06-17Warnings, Adverse reactionsExact identifier
rxcui: 2717083

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
2539a6cf-0fe5-1565-e063-6294a90a3618IMULDOSA 45 MG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML ustekinumab-srlf 90 MG/ML Prefilled Syringe [Imuldosa] [SBD] · Imuldosa 45 MG per 0.5 ML Prefilled Syringe [SY]39These highlights do not include all the information needed to use IMULDOSA safely and effectively. See full prescribing information for IMULDOSA. IMULDOSA (ustekinumab-srlf) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 IMULDOSA (ustekinumab-srlf) is biosimilar* to STELARA ® (ustekinumab)20251203