MedPath
FDA Product

Haloperidol

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

Basic Information

Haloperidol

60687-161

Regulatory Information

60687-161

ANDA077580

C73584

October 4, 2022

USA

Haloperidol Tablets, USP 8224901/0819 Rx only

HUMAN PRESCRIPTION DRUG LABEL

7

Company Information

929561009

Active Ingredients

CALCIUM STEARATE

Code: 776XM7047L

Class Code: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATE

Code: O7TSZ97GEP

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

HALOPERIDOL

Quantity: 5 mg in 1 1

Code: J6292F8L3D

Class Code: ACTIB

Active Moieties

HALOPERIDOL

Code: J6292F8L3D

© Copyright 2025. All Rights Reserved by MedPath