FDA Product

Haloperidol

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

Basic Information

Product Name

Haloperidol

FDA Product Code

63323-474

Regulatory Information

NDC Product Code

63323-474

Application Number

ANDA075689

Marketing Category

C73584

Effective Date

January 10, 2022

Territorial Authority

USA

FDA Title

Haloperidol Injection, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

11

Company Information

ManufacturerFresenius Kabi USA, LLC

DUNS Number

608775388

Active Ingredients

METHYLPARABEN

Quantity: 1.8 mg in 1 mL

Code: A2I8C7HI9T

Class Code: IACT

HALOPERIDOL LACTATE

Quantity: 5 mg in 1 mL

Code: 6387S86PK3

Class Code: ACTIM

PROPYLPARABEN

Quantity: 0.2 mg in 1 mL

Code: Z8IX2SC1OH

Class Code: IACT

LACTIC ACID

Code: 33X04XA5AT

Class Code: IACT

Active Moieties

HALOPERIDOL

Code: J6292F8L3D

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