NDC Code(s) : 0517-3405-25, 0517-3415-25, 0517-3450-25
Packager : American Regent, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sodium Phosphatessodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-3405
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sodium phosphate, monobasic, monohydrate(UNII: 593YOG76RN)
(phosphorus - UNII:27YLU75U4W) 		sodium phosphate, monobasic, monohydrate276 mg in 1 mL
sodium phosphate, dibasic anhydrous(UNII: 22ADO53M6F)
(sodium cation - UNII:LYR4M0NH37) 		sodium phosphate, dibasic anhydrous142 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-3405-2525 in 1 TRAY
15 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/30/1990
Sodium Phosphatessodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-3415
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sodium phosphate, monobasic, monohydrate(UNII: 593YOG76RN)
(phosphorus - UNII:27YLU75U4W) 		sodium phosphate, monobasic, monohydrate276 mg in 1 mL
sodium phosphate, dibasic anhydrous(UNII: 22ADO53M6F)
(sodium cation - UNII:LYR4M0NH37) 		sodium phosphate, dibasic anhydrous142 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-3415-2525 in 1 TRAY
115 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/30/1990
Sodium Phosphatessodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-3450
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sodium phosphate, monobasic, monohydrate(UNII: 593YOG76RN)
(phosphorus - UNII:27YLU75U4W) 		sodium phosphate, monobasic, monohydrate276 mg in 1 mL
sodium phosphate, dibasic anhydrous(UNII: 22ADO53M6F)
(sodium cation - UNII:LYR4M0NH37) 		sodium phosphate, dibasic anhydrous142 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-3450-2525 in 1 TRAY
150 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/30/1990

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 5 mL Container

NDC 0517-3405-25

SODIUM PHOSPHATES INJECTION, USP

15 mM/5 mL Phosphorus

20 mEq/ 5 mL Sodium

5 mL SINGLE DOSE VIAL

FOR IV USE AFTER DILUTION

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

PRINCIPAL DISPLAY PANEL - 5 mL Container

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 15 mL Container

NDC 0517-3415-25

SODIUM PHOSPHATES INJECTION, USP

45 mM/15 mL Phosphorus

60 mEq/15 mL Sodium

15 mL SINGLE DOSE VIAL

FOR IV USE AFTER DILUTION

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

PRINCIPAL DISPLAY PANEL – 15 mL Container

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 50 mL Container

NDC 0517-3450-25

SODIUM PHOSPHATES INJECTION, USP

150 mM/50 mL Phosphorus

200 mEq/50 mL Sodium

50 mL SINGLE DOSE VIAL

FOR IV USE AFTER DILUTION

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

PRINCIPAL DISPLAY PANEL – 50 mL Container