potassium citrate

FDA Drug Profile — UROCIT-K, POTASSIUM CITRATE, Potassium Citrate

potassium citrate is listed in the FDA National Drug Code directory with 12 NDC codes, marketed under brand names including UROCIT-K, POTASSIUM CITRATE, Potassium Citrate. Available dosage forms: tablet, extended release, tablet.

Drug Details

Generic Name
potassium citrate
Brand Names
UROCIT-K, POTASSIUM CITRATE, Potassium Citrate
Application Number
NDA019071
Sponsor
Mission Pharmacal Company
NDC Codes
12
Dosage Forms
TABLET, EXTENDED RELEASE, TABLET
Routes
ORAL
Active Ingredients
POTASSIUM CITRATE

Indications and Usage

1 INDICATIONS AND USAGE Potassium Citrate Extended-Release Tablets are a citrate salt of potassium indicated for the management of: Renal tubular acidosis (RTA) with calcium stones ( 1.1 ) Hypocitraturic calcium oxalate nephrolithiasis of any etiology ( 1.2 ) Uric acid lithiasis with or without calcium stones ( 1.3 ) 1.1 Renal Tubular Acidosis (RTA) with Calcium Stones Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies ( 14.1 )] . 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology Potassium citrate is indicated for the management of hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies ( 14.2 )] . 1.3 Uric Acid Lithiasis with or without Calcium Stones Potassium citrate is indicated for the management of uric acid lithiasis with or without calcium stones [see Clinical Studies ( 14.3 )] .