Active ingredient
Prochlorperazine
83 finished FDA listings contain Prochlorperazine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PROCHLORPERAZINE, PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE MALEATE
- Dosage forms
- Injection, Injection, Solution, Suppository, Tablet, Tablet, Film Coated
- Routes
- Intramuscular, Intravenous, Oral, Rectal
- Manufacturers / labelers
- 45
- Strengths listed
- 10 mg/1 · 25 mg/1 · 5 mg/1 · 5 mg/ml
- Brand names in FDA listings
- Compro
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8704
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 089903 | HIKMA | 1989-08-29 | 3 |
| ANDA 040058 | COSETTE PHARMS NC | 1993-11-24 | 1 |
| ANDA 040101 | CHARTWELL RX | 1996-07-19 | 2 |
| ANDA 040268 | JUBILANT CADISTA | 1998-02-27 | 20 |
| ANDA 040246 | PADAGIS US | 2000-06-28 | 2 |
| ANDA 204147 | AVET LIFESCIENCES | 2013-10-15 | 4 |
| ANDA 210710 | MYLAN LABS LTD | 2018-10-25 | 1 |
| ANDA 214379 | CAPLIN | 2021-04-22 | 2 |
| ANDA 214107 | GLAND | 2021-09-22 | 4 |
| ANDA 213626 | VIWIT PHARM | 2021-09-28 | 1 |
| ANDA 216202 | NOVITIUM PHARMA | 2022-06-13 | 5 |
| ANDA 213873 | EUGIA PHARMA | 2022-07-14 | 1 |
| ANDA 216495 | ZYDUS LIFESCIENCES | 2022-08-08 | 6 |
| ANDA 214192 | AMNEAL | 2022-11-28 | 1 |
| ANDA 216595 | GLENMARK PHARMS LTD | 2023-03-17 | 2 |
| ANDA 217478 | BIONPHARMA | 2023-04-04 | 13 |
| ANDA 216598 | AMNEAL | 2023-04-17 | 4 |
| ANDA 218515 | AJANTA PHARMA LTD | 2024-05-09 | 3 |
| ANDA 212257 | SOMERSET THERAPS LLC | 2024-09-13 | 1 |
| ANDA 218912 | LEADING | 2024-09-30 | 4 |
| ANDA 218734 | AUROBINDO PHARMA LTD | 2025-09-08 | 3 |
Official labeling on DailyMed
- PROCHLORPERAZINE MALEATE TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-07
- PROCHLORPERAZINE MALEATE TABLET [REMEDYREPACK INC.] · version 7 · 2026-09-02
- PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 3 · 2026-08-24
- PROCHLORPERAZINE MALEATE TABLET, FILM COATED [REMEDYREPACK INC.] · version 1 · 2026-08-21
- PROCHLORPERAZINE MALEATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 5 · 2026-08-10
- PROCHLORPERAZINE EDISYLATE INJECTION [SOMERSET THERAPEUTICS, LLC] · version 6 · 2026-07-21
- PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [SPORTPHARM LLC] · version 1 · 2026-07-13
- PROCHLORPERAZINE MALEATE TABLET [REMEDYREPACK INC.] · version 11 · 2026-07-13
- PROCHLORPERAZINE MALEATE TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.] · version 5 · 2026-07-13
- PROCHLORPERAZINE MALEATE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] · version 7 · 2026-06-30
- PROCHLORPERAZINE MALEATE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 16 · 2026-05-15
- PROCHLORPERAZINE EDISYLATE INJECTION [CAPLIN STERILES LIMITED] · version 6 · 2026-04-09
Showing the 12 most recent of 61 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.