FDA.reportPublic FDA data

fibrinogen, human 1 MG Injection [Fibryga]

RxCUI
1947382
RxNorm name
fibrinogen, human 1 MG Injection [Fibryga]
Display name
fibrinogen, human 1 MG Injection [Fibryga]
Full name
fibrinogen, human 1 MG Injection [Fibryga]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125612FibrygaFibrinogen (Human)351(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.

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
007a93f4-d84b-1fa9-51ed-32f6140bf423fibryga 1 MG Injection [PSN] · fibrinogen, human 1 MG Injection [Fibryga] [SBD] · Fibryga 1 MG Injection [SY]313These highlights do not include all the information needed to use FIBRYGA safely and effectively. See full prescribing information for FIBRYGA. FIBRYGA® [fibrinogen (human)] Lyophilized Powder for Reconstitution, For Intravenous Use Initial U.S. Approval: 201720240731
e3422d2a-2cb6-6f49-0be7-cb960b3d5bd5fibryga 1 MG Injection [PSN] · fibrinogen, human 1 MG Injection [Fibryga] [SBD] · Fibryga 1 MG Injection [SY]34These highlights do not include all the information needed to use FIBRYGA safely and effectively. See full prescribing information for FIBRYGA. FIBRYGA® [fibrinogen (human)] Lyophilized Powder for Reconstitution, For Intravenous Use Initial U.S. Approval: 201720250805