FDA.reportPublic FDA data

Baxdela 450 MG (as delafloxacin meglumine 649 MG) Oral Tablet

RxCUI
1927682
RxNorm name
Baxdela 450 MG (as delafloxacin meglumine 649 MG) Oral Tablet
Display name
Baxdela 450 MG (as delafloxacin meglumine 649 MG) Oral Tablet
Full name
Baxdela 450 MG (as delafloxacin meglumine 649 MG) Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:29

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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
BaxdelaDELAFLOXACIN MEGLUMINEMelinta Therapeutics, LLCfb77637a-88d9-4aea-958f-e270030ce30d2025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1927682

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
fb77637a-88d9-4aea-958f-e270030ce30dBaxdela 450 MG Oral Tablet [PSN] · delafloxacin 450 MG Oral Tablet [Baxdela] [SBD] · Baxdela 450 MG (as delafloxacin meglumine 649 MG) Oral Tablet [SY] · Baxdela 450 MG Oral Tablet [SY]421These highlights do not include all the information needed to use BAXDELA ® safely and effectively. See full prescribing information for BAXDELA. BAXDELA (delafloxacin) tablets, for oral use BAXDELA (delafloxacin) for injection, for intravenous use Initial U.S. Approval: 201720250801