FDA.reportPublic FDA data

ovine digoxin immune fab 40 MG Injection [DigiFab]

RxCUI
404702
RxNorm name
ovine digoxin immune fab 40 MG Injection [DigiFab]
Display name
ovine digoxin immune fab 40 MG Injection [DigiFab]
Full name
ovine digoxin immune fab 40 MG Injection [DigiFab]
Term type
SBD
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)Rx2026-08-01

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.

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-40781639d653DigiFab 40 MG Injection [PSN] · ovine digoxin immune fab 40 MG Injection [DigiFab] [SBD] · DigiFab 40 MG Injection [SY]38These 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-e063-6294a90a410eDigiFab 40 MG Injection [PSN] · ovine digoxin immune fab 40 MG Injection [DigiFab] [SBD] · DigiFab 40 MG Injection [SY]34These 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