FDA Product

Haloperidol

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

Basic Information

Product Name

Haloperidol

FDA Product Code

71247-155

Regulatory Information

NDC Product Code

71247-155

Application Number

ANDA071173

Marketing Category

C73584

Effective Date

February 18, 2021

Territorial Authority

USA

FDA Title

HALOPERIDOL TABLETS, USP Rx only

Labeling Type

Human Prescription Drug Label

Version Number

2

Company Information

ManufacturerInnogenix, Inc.

DUNS Number

080501434

Active Ingredients

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

Quantity: 20 mg in 1 1

Code: J6292F8L3D

Class Code: ACTIB

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

Active Moieties

HALOPERIDOL

Code: J6292F8L3D

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