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)Rx2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
0ea37235-35fd-410d-b8c4-40ba15fe1294REBINYN 1 UNT InjectionPSN9These 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
0ea37235-35fd-410d-b8c4-40ba15fe1294Rebinyn 1 UNT InjectionSY9These 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
0ea37235-35fd-410d-b8c4-40ba15fe1294coagulation factor IX (recombinant), glycopegylated 1 UNT Injection [Rebinyn]SBD9These 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