Active ingredient
Arimoclomol
4 finished FDA listings contain Arimoclomol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ARIMOCLOMOL CITRATE
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 124 mg/1 · 47 mg/1 · 62 mg/1 · 93 mg/1
- Brand names in FDA listings
- Miplyffa
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2694283
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 214927 | ZEVRA DENMARK | 2024-09-20 | 4 |
Official labeling on DailyMed
- MIPLYFFA (ARIMOCLOMOL CITRATE) CAPSULE [ACER THERAPEUTICS INC.] · version 5 · 2026-03-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.