FDA.reportPublic FDA data

incobotulinumtoxinA 50 UNT Injection

RxCUI
1009459
RxNorm name
incobotulinumtoxinA 50 UNT Injection
Display name
incobotulinumtoxinA 50 UNT Injection
Full name
incobotulinumtoxinA 50 UNT Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:21

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125360XeominincobotulinumtoxinA351(a)Rx2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XeominINCOBOTULINUMTOXINAMerz Pharmaceuticals, LLCccdc3aae-6e2d-4cd0-a51c-8375bfee94582026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1009459
XeominINCOBOTULINUMTOXINAMerz North America, Inc.3f35d6e0-3450-4abc-a0da-cc7b277e7c6e2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1009459

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
ccdc3aae-6e2d-4cd0-a51c-8375bfee9458incobotulinumtoxinA 50 UNT InjectionPSN32These highlights do not include all the information needed to use XEOMIN ® safely and effectively. See full prescribing information for XEOMIN. XEOMIN (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use Initial U.S. Approval: 201020260325
ccdc3aae-6e2d-4cd0-a51c-8375bfee9458incobotulinumtoxinA 50 UNT InjectionSCD32These highlights do not include all the information needed to use XEOMIN ® safely and effectively. See full prescribing information for XEOMIN. XEOMIN (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use Initial U.S. Approval: 201020260325
3f35d6e0-3450-4abc-a0da-cc7b277e7c6eincobotulinumtoxinA 50 UNT InjectionPSN26These highlights do not include all the information needed to use XEOMIN ® safely and effectively. See full prescribing information for XEOMIN. XEOMIN (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use Initial U.S. Approval: 201020260304
3f35d6e0-3450-4abc-a0da-cc7b277e7c6eincobotulinumtoxinA 50 UNT InjectionSCD26These highlights do not include all the information needed to use XEOMIN ® safely and effectively. See full prescribing information for XEOMIN. XEOMIN (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use Initial U.S. Approval: 201020260304