FDA.reportPublic FDA data

ovine digoxin immune fab 40 MG Injection

RxCUI
349326
RxNorm name
ovine digoxin immune fab 40 MG Injection
Display name
ovine digoxin immune fab 40 MG Injection
Full name
ovine digoxin immune fab 40 MG Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:19

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103910DigifabDigoxin Immune Fab (Ovine)351(a)Rx2026-09-01

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
c05ee6a5-c98b-45f4-83fd-40781639d653digoxin immune fab (ovine) 40 MG Injection [PSN] · ovine digoxin immune fab 40 MG Injection [SCD]28These highlights do not include all the information needed to use DIGIFAB safely and effectively. See full prescribing information for DIGIFAB. DigiFab ® , Digoxin Immune Fab (Ovine) For Intravenous Injection Only – Lyophilized Powder for Solution Initial U.S. Approval: 200120250124
49ee0505-77a0-1ff4-e063-6294a90a410edigoxin immune fab (ovine) 40 MG Injection [PSN] · ovine digoxin immune fab 40 MG Injection [SCD]24These highlights do not include all the information needed to use DIGIFAB safely and effectively. See full prescribing information for DIGIFAB. DigiFab ® , Digoxin Immune Fab (Ovine) For Intravenous Injection Only – Lyophilized Powder for Solution Initial U.S. Approval: 200120260413