FDA Product

Haloperidol

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

Basic Information

Product Name

Haloperidol

FDA Product Code

70518-0035

Regulatory Information

NDC Product Code

70518-0035

Application Number

ANDA075689

Marketing Category

C73584

Effective Date

May 11, 2023

Territorial Authority

USA

FDA Title

Haloperidol Injection, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

9

Company Information

ManufacturerREMEDYREPACK INC.

DUNS Number

829572556

Active Ingredients

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

HALOPERIDOL LACTATE

Quantity: 5 mg in 1 mL

Code: 6387S86PK3

Class Code: ACTIM

Active Moieties

HALOPERIDOL

Code: J6292F8L3D

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