FDA Product

Potassium Chloride

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

Basic Information

Product Name

Potassium Chloride

FDA Product Code

33261-215

Regulatory Information

NDC Product Code

33261-215

Application Number

NDA019123

Marketing Category

C73594

Effective Date

January 23, 2014

Territorial Authority

USA

FDA Title

Potassium Chloride Extended-release Tablets, USP 8 mEq and 10 mEq

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerAidarex Pharmaceuticals LLC

DUNS Number

801503249

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POTASSIUM CHLORIDE

Quantity: 750 mg in 1 1

Code: 660YQ98I10

Class Code: ACTIB

HYDROGENATED COTTONSEED OIL

Code: Z82Y2C65EA

Class Code: IACT

POLYVINYL ALCOHOL

Code: 532B59J990

Class Code: IACT

POLYETHYLENE GLYCOLS

Code: 3WJQ0SDW1A

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

Active Moieties

POTASSIUM CATION

Code: 295O53K152

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