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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 213392

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NDA 213392 describes POTASSIUM CHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Adare Pharms Inc, Amneal Pharms, Chartwell Molecular, Glenmark Pharms Ltd, Granules, Lupin Ltd, Nesher Pharms, Novel Labs Inc, Padagis Us, Ph Health, Prinston Inc, Strides Pharma, Teva, Tris Pharma Inc, Zydus Pharms, Ajenat Pharms, Amneal, Anda Repository, Epic Pharma Llc, Genus, Novitium Pharma, Rubicon Research, Abraxis Pharm, B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Intl Medication, Lilly, Luitpold, Miles, Nexus, Pharma Serve Ny, Watson Labs, Apotex, Ascent Pharms Inc, Genus Lifesciences, Macleods Pharms Ltd, Pharm Assoc, Sciegen Pharms Inc, Taro, Wes Pharma Inc, Aurobindo Pharma, Aurobindo Pharma Ltd, Breckenridge, Chartwell Rx, Copley Pharm, Guangzhou Novaken, Pharmobedient, Rising, Schering, Sigmapharm Labs Llc, Twi Pharms, Yichang Humanwell, Otsuka Icu Medcl, and Icu Medical Inc, and is included in one hundred and thirty-five NDAs. It is available from eighty suppliers. Additional details are available on the POTASSIUM CHLORIDE profile page.

The generic ingredient in POTASSIUM CHLORIDE is calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate profile page.

Summary for 213392

Tradename:	POTASSIUM CHLORIDE
Applicant:	Granules
Ingredient:	potassium chloride
Patents:	0

Pharmacology for NDA: 213392

Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Suppliers and Packaging for NDA: 213392

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
POTASSIUM CHLORIDE	potassium chloride	SOLUTION;ORAL	213392	ANDA	Granules Pharmaceuticals Inc.	70010-072	70010-072-44	473 mL in 1 BOTTLE (70010-072-44)
POTASSIUM CHLORIDE	potassium chloride	SOLUTION;ORAL	213392	ANDA	Granules Pharmaceuticals Inc.	70010-073	70010-073-44	473 mL in 1 BOTTLE (70010-073-44)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	20MEQ/15ML
Approval Date:	Jan 29, 2021	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	40MEQ/15ML
Approval Date:	Jan 29, 2021	TE:	AA	RLD:	No

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