FDA.reportPublic FDA data

XIAFLEX 0.9 MG Injection

RxCUI
898499
RxNorm name
XIAFLEX 0.9 MG Injection
Display name
XIAFLEX 0.9 MG Injection
Full name
XIAFLEX 0.9 MG Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125338Xiaflexcollagenase clostridium histolyticum351(a)Rx2026-10-01

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
805cecd0-fd1f-11dd-87af-0800200c9a66XIAFLEX 0.9 MG Injection [PSN] · collagenase Clostridium histolyticum 0.9 MG Injection [Xiaflex] [SBD] · Xiaflex 0.9 MG Injection [SY]346These highlights do not include all the information needed to use XIAFLEX safely and effectively. See full prescribing information for XIAFLEX. XIAFLEX ® (collagenase clostridium histolyticum) for injection, for intralesional use Initial U.S. Approval: 201020260422