HALDOL DECANOATE Solution for injection Ref.[27461] Active ingredients: Haloperidol

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Haloperidol decanoate is the decanoate ester of the butyrophenone, HALDOL (haloperidol). It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-(4-chlorophenyl)1[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is:

Haloperidol decanoate is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents.

Each mL of HALDOL decanoate 50 for IM injection contains 50 mg haloperidol (present as haloperidol decanoate 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.

Each mL of HALDOL decanoate 100 for IM injection contains 100 mg haloperidol (present as haloperidol decanoate 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.

How Supplied

HALDOL (haloperidol) decanoate 50 for IM injection, 50 mg haloperidol as 70.52 mg per mL haloperidol decanoate:

NDC 50458-253-03 3 × 1 mL ampules.

HALDOL (haloperidol) decanoate 100 for IM injection, 100 mg haloperidol as 141.04 mg per mL haloperidol decanoate:

NDC 50458-254-14, 5 × 1 mL ampules.

Product of Belgium

Manufactured by:

Janssen Pharmaceutica NV, Beerse, Belgium

Or

GlaxoSmithKline Manufacturing S.p.A., Parma, Italy

Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560

Drugs

Drug Countries
HALDOL DECANOATE Austria, Australia, Germany, Ireland, Malta, United Kingdom, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.