FDA Product

Haloperidol

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

Basic Information

Product Name

Haloperidol

FDA Product Code

0904-7112

Regulatory Information

NDC Product Code

0904-7112

Application Number

ANDA073364

Marketing Category

C73584

Effective Date

June 17, 2021

Territorial Authority

USA

FDA Title

Haloperidol Oral Solution USP (Concentrate) 2 mg per mL Rx only.

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerMajor Pharmaceuticals

DUNS Number

191427277

Active Ingredients

HALOPERIDOL LACTATE

Quantity: 2 mg in 1 mL

Code: 6387S86PK3

Class Code: ACTIM

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

LACTIC ACID, UNSPECIFIED FORM

Code: 33X04XA5AT

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

HALOPERIDOL

Code: J6292F8L3D

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