Active ingredient
Pimozide
4 finished FDA listings contain Pimozide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PIMOZIDE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 1 mg/1 · 2 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8331
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 204521 | PH HEALTH | 2015-09-28 | 2 |
| ANDA 219897 | NOVITIUM PHARMA | 2026-04-13 | 2 |
Official labeling on DailyMed
- PIMOZIDE TABLET [PAR HEALTH USA, LLC] · version 5 · 2026-09-07
- PIMOZIDE TABLET [ANI PHARMACEUTICALS, INC.] · version 3 · 2026-07-15
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.