FDA Product

haloperidol

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

Basic Information

Product Name

haloperidol

FDA Product Code

70518-3737

Regulatory Information

NDC Product Code

70518-3737

Application Number

ANDA091637

Marketing Category

C73584

Effective Date

March 28, 2024

Territorial Authority

USA

FDA Title

Haloperidol Injection, USP (For Immediate Release) (For Intramuscular Use)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerREMEDYREPACK INC.

DUNS Number

829572556

Active Ingredients

LACTIC ACID

Code: 33X04XA5AT

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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