NDC Code(s) : 0517-2053-25
Packager : American Regent, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Potassium AcetatePotassium Acetate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-2053
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM ACETATE(UNII: M911911U02)
(POTASSIUM CATION - UNII:295O53K152) 		POTASSIUM ACETATE196 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID(UNII: Q40Q9N063P)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-2053-2525 in 1 TRAY 30/09/1990
120 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/30/1990 11/29/2012

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0517-2053-25

POTASSIUM ACETATE
INJECTION, USP
40 mEq/20 mL
(2 Meq/mL)
20 mL SINGLE DOSE VIAL
FOR IV USE AFTER DILUTION
Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY  11967

Container Label