FDA Product

Haloperidol

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Haloperidol

FDA Product Code

55154-9553

Regulatory Information

NDC Product Code

55154-9553

Application Number

ANDA075689

Marketing Category

C73584

Effective Date

April 27, 2020

Territorial Authority

USA

FDA Title

Haloperidol Injection, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

12

Company Information

ManufacturerCardinal Health 107, LLC

DUNS Number

118546603

Active Ingredients

HALOPERIDOL LACTATE

Quantity: 5 mg in 1 mL

Code: 6387S86PK3

Class Code: ACTIM

METHYLPARABEN

Quantity: 1.8 mg in 1 mL

Code: A2I8C7HI9T

Class Code: IACT

LACTIC ACID, UNSPECIFIED FORM

Code: 33X04XA5AT

Class Code: IACT

PROPYLPARABEN

Quantity: 0.2 mg in 1 mL

Code: Z8IX2SC1OH

Class Code: IACT

Active Moieties

HALOPERIDOL

Code: J6292F8L3D

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