FDA.reportPublic FDA data

Botox 200 UNT/ML Injectable Solution

RxCUI
897368
RxNorm name
Botox 200 UNT/ML Injectable Solution
Display name
Botox 200 UNT/ML Injectable Solution
Full name
Botox 200 UNT/ML Injectable Solution
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:53

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103000Botox CosmeticonabotulinumtoxinA351(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#

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
BOTOXONABOTULINUMTOXINAAllergan, Inc.33d066a9-34ff-4a1a-b38b-d10983df33002023-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897368

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
33d066a9-34ff-4a1a-b38b-d10983df3300Botox 200 UNT/ML Injectable SolutionSY61These highlights do not include all the information needed to use BOTOX ® safely and effectively. See full prescribing information for BOTOX. BOTOX ® (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use Initial U.S. Approval: 198920231118
33d066a9-34ff-4a1a-b38b-d10983df3300Botox 200 UNT InjectionPSN61These highlights do not include all the information needed to use BOTOX ® safely and effectively. See full prescribing information for BOTOX. BOTOX ® (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use Initial U.S. Approval: 198920231118
33d066a9-34ff-4a1a-b38b-d10983df3300onabotulinumtoxinA 200 UNT Injection [Botox]SBD61These highlights do not include all the information needed to use BOTOX ® safely and effectively. See full prescribing information for BOTOX. BOTOX ® (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use Initial U.S. Approval: 198920231118
33d066a9-34ff-4a1a-b38b-d10983df3300Botox 200 UNT InjectionSY61These highlights do not include all the information needed to use BOTOX ® safely and effectively. See full prescribing information for BOTOX. BOTOX ® (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use Initial U.S. Approval: 198920231118