FDA Product

Haloperidol

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

Basic Information

Product Name

Haloperidol

FDA Product Code

0143-9501

Regulatory Information

NDC Product Code

0143-9501

Application Number

ANDA075858

Marketing Category

C73584

Effective Date

November 16, 2023

Territorial Authority

USA

FDA Title

HALOPERIDOL INJECTION USP (For Immediate Release)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

10

Company Information

ManufacturerHikma Pharmaceuticals USA Inc.

DUNS Number

001230762

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

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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