Active ingredient
Molindone
3 finished FDA listings contain Molindone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MOLINDONE HYDROCHLORIDE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 10 mg/1 · 25 mg/1 · 5 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7019
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 |
|---|---|---|---|
| ANDA 090453 | EPIC PHARMA LLC | 2015-03-20 | 3 |
Official labeling on DailyMed
- MOLINDONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] · version 5 · 2025-12-19
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.