FDA.reportPublic FDA data

abatacept 50 MG in 0.4 ML Prefilled Syringe

RxCUI
1925254
RxNorm name
abatacept 50 MG in 0.4 ML Prefilled Syringe
Display name
abatacept 50 MG in 0.4 ML Prefilled Syringe
Full name
abatacept 50 MG in 0.4 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125118Orenciaabatacept351(a)Rx2026-07-01

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORENCIAABATACEPTE.R. Squibb & Sons, L.L.C.0836c6ac-ee37-5640-2fed-a3185a0b16eb2025-11-13Warnings, Adverse reactionsExact identifier
rxcui: 1925254

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
0836c6ac-ee37-5640-2fed-a3185a0b16ebabatacept 50 MG in 0.4 ML Prefilled Syringe [PSN] · 0.4 ML abatacept 125 MG/ML Prefilled Syringe [SCD] · abatacept 50 MG per 0.4 ML Prefilled Syringe [SY]335These highlights do not include all the information needed to use ORENCIA safely and effectively. See full prescribing information for ORENCIA. ORENCIA (abatacept) for injection, for intravenous use ORENCIA (abatacept) injection, for subcutaneous use Initial U.S. Approval: 200520251113