FDA.reportPublic FDA data

Miplyffa 62 MG (equivalent to 100 MG arimoclomol citrate) Oral Capsule

RxCUI
2694302
RxNorm name
Miplyffa 62 MG (equivalent to 100 MG arimoclomol citrate) Oral Capsule
Display name
Miplyffa 62 MG (equivalent to 100 MG arimoclomol citrate) Oral Capsule
Full name
Miplyffa 62 MG (equivalent to 100 MG arimoclomol citrate) Oral Capsule
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:00

RxNav Current And Historical NDCs#

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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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MIPLYFFAARIMOCLOMOL CITRATEAcer Therapeutics Inc.5feffc0e-453d-47fa-91dd-38d4952309bc2026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 2694302

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
5feffc0e-453d-47fa-91dd-38d4952309bcMiplyffa 62 MG (equivalent to 100 MG arimoclomol citrate) Oral CapsuleSY5These highlights do not include all the information needed to use MIPLYFFA ® safely and effectively. See full prescribing information for MIPLYFFA. MIPLYFFA (arimoclomol) capsules, for oral use Initial U.S. Approval: 202420260318
5feffc0e-453d-47fa-91dd-38d4952309bcMIPLYFFA 62 MG Oral CapsulePSN5These highlights do not include all the information needed to use MIPLYFFA ® safely and effectively. See full prescribing information for MIPLYFFA. MIPLYFFA (arimoclomol) capsules, for oral use Initial U.S. Approval: 202420260318
5feffc0e-453d-47fa-91dd-38d4952309bcarimoclomol 62 MG Oral Capsule [Miplyffa]SBD5These highlights do not include all the information needed to use MIPLYFFA ® safely and effectively. See full prescribing information for MIPLYFFA. MIPLYFFA (arimoclomol) capsules, for oral use Initial U.S. Approval: 202420260318