Active ingredient
Haloperidol
232 finished FDA listings contain Haloperidol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- HALOPERIDOL, HALOPERIDOL DECANOATE, HALOPERIDOL LACTATE
- Dosage forms
- Injection, Injection, Solution, Solution, Solution, Concentrate, Tablet
- Routes
- Intramuscular, Oral
- Manufacturers / labelers
- 42
- Strengths listed
- .5 mg/1 · 1 mg/1 · 10 mg/1 · 100 mg/ml · 2 mg/1 · 2 mg/ml · 20 mg/1 · 250 mg/5ml · 5 mg/1 · 5 mg/ml · 50 mg/ml · 500 mg/5ml
- Brand names in FDA listings
- Haloperidol, Haloperidol Lactate
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 5093
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 018701 | JANSSEN PHARMS | 1986-01-14 | 2 |
| ANDA 070278 | MYLAN | 1986-06-10 | 10 |
| ANDA 071130 | AIPING PHARM INC | 1987-02-17 | 12 |
| ANDA 071173 | SCIEGEN PHARMS | 1988-01-07 | 56 |
| ANDA 073037 | PHARM ASSOC | 1993-02-26 | 2 |
| ANDA 073364 | LANNETT CO INC | 1993-09-28 | 1 |
| ANDA 074893 | FRESENIUS KABI USA | 1997-12-19 | 3 |
| ANDA 075305 | HIKMA | 1998-09-28 | 2 |
| ANDA 075440 | MYLAN LABS LTD | 2000-02-28 | 2 |
| ANDA 075689 | FRESENIUS KABI USA | 2001-03-09 | 4 |
| ANDA 075858 | HIKMA | 2001-06-18 | 3 |
| ANDA 077580 | ZYDUS PHARMS USA | 2007-11-29 | 30 |
| ANDA 078347 | MYLAN LABS LTD | 2009-09-14 | 4 |
| ANDA 205241 | GLAND | 2017-05-12 | 5 |
| ANDA 209101 | SOMERSET THERAPS LLC | 2018-07-03 | 11 |
| ANDA 211180 | ZYDUS PHARMS | 2019-10-22 | 11 |
| ANDA 211061 | APPCO | 2020-01-08 | 6 |
| ANDA 214507 | MEITHEAL | 2021-07-26 | 4 |
| ANDA 216004 | MSN | 2022-11-18 | 6 |
| ANDA 216730 | MANKIND PHARMA | 2023-05-23 | 7 |
| ANDA 218371 | RUBICON RESEARCH | 2024-01-31 | 1 |
| ANDA 216918 | MANKIND PHARMA | 2024-04-11 | 11 |
| ANDA 218789 | AUROBINDO PHARMA LTD | 2024-04-19 | 11 |
| ANDA 219168 | CAPLIN | 2025-05-13 | 10 |
| ANDA 218162 | CREEKWOOD PHARMS | 2025-12-18 | 12 |
| ANDA 218210 | AJANTA PHARMA LTD | 2026-09-14 | 6 |
Official labeling on DailyMed
- HALOPERIDOL TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-02
- HALOPERIDOL DECANOATE INJECTION [REMEDYREPACK INC.] · version 4 · 2026-09-02
- HALOPERIDOL TABLET [REMEDYREPACK INC.] · version 1 · 2026-08-17
- HALOPERIDOL TABLET [UPSHER-SMITH LABORATORIES, LLC] · version 7 · 2026-08-07
- HALOPERIDOL TABLET [COUPLER LLC] · version 1 · 2026-08-05
- HALOPERIDOL TABLET [REMEDYREPACK INC.] · version 9 · 2026-08-03
- HALOPERIDOL DECANOATE INJECTION [ZYDUS PHARMACEUTICALS USA INC.] · version 10 · 2026-07-23
- HALOPERIDOL LACTATE INJECTION, SOLUTION [REMEDYREPACK INC.] · version 10 · 2026-07-15
- HALOPERIDOL DECANOATE INJECTION [GLAND PHARMA LIMITED] · version 15 · 2026-07-15
- HALOPERIDOL TABLET [REMEDYREPACK INC.] · version 14 · 2026-07-10
- HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC] · version 14 · 2026-07-01
- HALOPERIDOL TABLET [UNIT DOSE SOLUTIONS, INC.] · version 1 · 2026-06-24
Showing the 12 most recent of 108 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.