Haloperidol Lactate

Basic Information

Product Name

Haloperidol Lactate

FDA Product Code

0404-9871

Regulatory Information

NDC Product Code

0404-9871

Application Number

ANDA078347

Marketing Category

C73584

Effective Date

January 11, 2022

Territorial Authority

USA

FDA Title

Haloperidol Injection, USP (For Immediate Release) Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

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

PROPYLPARABEN

Quantity: 0.2 mg in 1 mL

Code: Z8IX2SC1OH

Class Code: IACT

LACTIC ACID

Code: 33X04XA5AT

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

HALOPERIDOL

Code: J6292F8L3D

Basic Information

Regulatory Information

Company Information

Active Ingredients

METHYLPARABEN

PROPYLPARABEN

LACTIC ACID

WATER

Active Moieties

HALOPERIDOL