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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.

ApplicationSponsorOriginal approvalListings
NDA 018701JANSSEN PHARMS1986-01-142
ANDA 070278MYLAN1986-06-1010
ANDA 071130AIPING PHARM INC1987-02-1712
ANDA 071173SCIEGEN PHARMS1988-01-0756
ANDA 073037PHARM ASSOC1993-02-262
ANDA 073364LANNETT CO INC1993-09-281
ANDA 074893FRESENIUS KABI USA1997-12-193
ANDA 075305HIKMA1998-09-282
ANDA 075440MYLAN LABS LTD2000-02-282
ANDA 075689FRESENIUS KABI USA2001-03-094
ANDA 075858HIKMA2001-06-183
ANDA 077580ZYDUS PHARMS USA2007-11-2930
ANDA 078347MYLAN LABS LTD2009-09-144
ANDA 205241GLAND2017-05-125
ANDA 209101SOMERSET THERAPS LLC2018-07-0311
ANDA 211180ZYDUS PHARMS2019-10-2211
ANDA 211061APPCO2020-01-086
ANDA 214507MEITHEAL2021-07-264
ANDA 216004MSN2022-11-186
ANDA 216730MANKIND PHARMA2023-05-237
ANDA 218371RUBICON RESEARCH2024-01-311
ANDA 216918MANKIND PHARMA2024-04-1111
ANDA 218789AUROBINDO PHARMA LTD2024-04-1911
ANDA 219168CAPLIN2025-05-1310
ANDA 218162CREEKWOOD PHARMS2025-12-1812
ANDA 218210AJANTA PHARMA LTD2026-09-146

Official labeling on DailyMed

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.