FDA.reportPublic FDA data

collagenase Clostridium histolyticum 0.9 MG Injection

RxCUI
898495
RxNorm name
collagenase Clostridium histolyticum 0.9 MG Injection
Display name
collagenase Clostridium histolyticum 0.9 MG Injection
Full name
collagenase Clostridium histolyticum 0.9 MG Injection
Term type
SCD
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)Rx2026-07-01

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.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XIAFLEXCOLLAGENASE CLOSTRIDIUM HISTOLYTICUMEndo USA, Inc.805cecd0-fd1f-11dd-87af-0800200c9a662026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 898495

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-0800200c9a66collagenase Clostridium histolyticum 0.9 MG Injection [PSN] · collagenase Clostridium histolyticum 0.9 MG Injection [SCD] · collagenase Clostridium histolyticum 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