FDA.reportPublic FDA data

1 ML rimabotulinumtoxinB 5000 UNT/ML Injection [Myobloc]

RxCUI
1736648
RxNorm name
1 ML rimabotulinumtoxinB 5000 UNT/ML Injection [Myobloc]
Display name
1 ML rimabotulinumtoxinB 5000 UNT/ML Injection [Myobloc]
Full name
1 ML rimabotulinumtoxinB 5000 UNT/ML Injection [Myobloc]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:01

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103846MyoblocrimabotulinumtoxinB351(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
MyoblocRIMABOTULINUMTOXINBSolstice Neurosciences, LLC675cb354-9d13-482e-8ac2-22f709c58b4f2025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1736648

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
675cb354-9d13-482e-8ac2-22f709c58b4fMYOBLOC 5000 UNT in 1 ML Injection [PSN] · 1 ML rimabotulinumtoxinB 5000 UNT/ML Injection [Myobloc] [SBD] · Myobloc 5000 UNT per 1 ML Injection [SY]320These highlights do not include all the information needed to use MYOBLOC ® safely and effectively. See full prescribing information for MYOBLOC ® . MYOBLOC ® (rimabotulinumtoxinB) injection, for intramuscular or intraglandular use Initial U.S. Approval: 200020251022