FDA Product

Haloperidol

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

Basic Information

Product Name

Haloperidol

FDA Product Code

76045-737

Regulatory Information

NDC Product Code

76045-737

Application Number

ANDA210356

Marketing Category

C73584

Effective Date

November 30, 2019

Territorial Authority

USA

FDA Title

Haloperidol Injection, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

18

Company Information

ManufacturerFresenius Kabi USA, LLC

DUNS Number

608775388

Active Ingredients

Haloperidol lactate

Quantity: 5 mg in 1 mL

Code: 6387S86PK3

Class Code: ACTIM

LACTIC ACID, UNSPECIFIED FORM

Code: 33X04XA5AT

Class Code: IACT

Active Moieties

Haloperidol

Code: J6292F8L3D

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