FDA Product

Haloperidol

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

Basic Information

Product Name

Haloperidol

FDA Product Code

68083-117

Regulatory Information

NDC Product Code

68083-117

Application Number

ANDA076774

Marketing Category

C73584

Effective Date

November 4, 2022

Territorial Authority

USA

FDA Title

HALOPERIDOL INJECTION USP (For Immediate Release) Preservative Free Rx only

Labeling Type

Human Prescription Drug Label

Version Number

9

Company Information

ManufacturerGland Pharma Limited

DUNS Number

918601238

Active Ingredients

HALOPERIDOL LACTATE

Quantity: 5 mg in 1 mL

Code: 6387S86PK3

Class Code: ACTIM

LACTIC ACID

Code: 33X04XA5AT

Class Code: IACT

Active Moieties

HALOPERIDOL

Code: J6292F8L3D

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