FDA Product

Haloperidol

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

Basic Information

Product Name

Haloperidol

FDA Product Code

63629-9271

Regulatory Information

NDC Product Code

63629-9271

Application Number

ANDA071173

Marketing Category

C73584

Effective Date

December 2, 2019

Territorial Authority

USA

FDA Title

Haloperidol Tablets, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

101

Company Information

ManufacturerBryant Ranch Prepack

DUNS Number

171714327

Active Ingredients

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

Quantity: 1 mg in 1 1

Code: J6292F8L3D

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

HALOPERIDOL

Code: J6292F8L3D

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