FDA.reportPublic FDA data

REBINYN 1 UNT Injection

RxCUI
1990862
RxNorm name
REBINYN 1 UNT Injection
Display name
REBINYN 1 UNT Injection
Full name
REBINYN 1 UNT Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125611RebinynCoagulation Factor IX (Recombinant), GlycoPEGylated351(a)Rx2026-08-01

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
REBINYNCOAGULATION FACTOR IX RECOMBINANT, GLYCOPEGYLATEDNovo Nordisk0ea37235-35fd-410d-b8c4-40ba15fe12942022-08-11Warnings, Adverse reactionsExact identifier
rxcui: 1990862

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
0ea37235-35fd-410d-b8c4-40ba15fe1294REBINYN 1 UNT Injection [PSN] · coagulation factor IX (recombinant), glycopegylated 1 UNT Injection [Rebinyn] [SBD] · Rebinyn 1 UNT Injection [SY]39These highlights do not include all the information needed to use REBINYN safely and effectively. See full prescribing information for REBINYN. REBINYN ® (Coagulation Factor IX (Recombinant), GlycoPEGylated) lyophilized powder for solution for intravenous injection Initial U.S. Approval: 201720220811