FDA Product

IDkit HP ONE

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

Basic Information

Product Name

IDkit HP ONE

FDA Product Code

50402-100

Regulatory Information

NDC Product Code

50402-100

Application Number

NDA021314

Marketing Category

C73594

Effective Date

September 14, 2023

Territorial Authority

USA

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

4

Company Information

ManufacturerMeridian Bioscience Israel Ltd

DUNS Number

514832786

Active Ingredients

Quantity: 75 mg in 1 1

Code: W6KX9E6D8X

Class Code: ACTIB

CITRIC ACID MONOHYDRATE

Quantity: 4 g in 1 1

Code: 2968PHW8QP

Class Code: ACTIM

Active Moieties

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

UREA C-13

Code: W6KX9E6D8X

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