NDC Code(s) : 65219-052-09, 65219-052-29, 65219-054-09, 65219-054-29, 65219-056-09, 65219-056-29
Packager : Fresenius Kabi USA, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Potassium PhosphatesPotassium Phosphate, Monobasic Potassium Phosphate, Dibasic INJECTION, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65219-052
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Potassium Phosphate, Monobasic(UNII: 4J9FJ0HL51)
(Phosphate Ion - UNII:NK08V8K8HR) 		Potassium Phosphate, Monobasic224 mg in 1 mL
Potassium Phosphate, Dibasic(UNII: CI71S98N1Z)
(Phosphate Ion - UNII:NK08V8K8HR) 		Potassium Phosphate, Dibasic236 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65219-052-2925 in 1 TRAY 02/10/2020
1NDC:65219-052-095 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
NDA NDA212832 02/10/2020
Potassium PhosphatesPotassium Phosphate, Monobasic Potassium Phosphate, Dibasic INJECTION, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65219-054
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Potassium Phosphate, Monobasic(UNII: 4J9FJ0HL51)
(Phosphate Ion - UNII:NK08V8K8HR) 		Potassium Phosphate, Monobasic224 mg in 1 mL
Potassium Phosphate, Dibasic(UNII: CI71S98N1Z)
(Phosphate Ion - UNII:NK08V8K8HR) 		Potassium Phosphate, Dibasic236 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65219-054-2925 in 1 TRAY 02/10/2020
1NDC:65219-054-0915 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
NDA NDA212832 02/10/2020
Potassium PhosphatesPotassium Phosphate, Monobasic Potassium Phosphate, Dibasic INJECTION, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65219-056
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Potassium Phosphate, Monobasic(UNII: 4J9FJ0HL51)
(Phosphate Ion - UNII:NK08V8K8HR) 		Potassium Phosphate, Monobasic224 mg in 1 mL
Potassium Phosphate, Dibasic(UNII: CI71S98N1Z)
(Phosphate Ion - UNII:NK08V8K8HR) 		Potassium Phosphate, Dibasic236 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65219-056-2925 in 1 TRAY 02/10/2020
1NDC:65219-056-0950 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212832 02/10/2020

LABELER - Fresenius Kabi USA, LLC(013547657)

Establishment
Name Address ID/FEI Business Operations
Fresenius Kabi USA, LLC 840771732 MANUFACTURE(65219-052, 65219-054, 65219-056)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Phosphates Inj, USP 5 mL Vial Label

NDC 65219-052-09        860529

POTASSIUM

PHOSPHATES

INJECTION, USP

Phosphorus 15 mmol/5 mL

(3 mmol/mL)

Potassium 22 mEq/5 mL

(4.4 mEq/mL)

CAUTION: MUST BE DILUTED

For Intravenous use only

5 mL Single-Dose Vial Rx only

Discard Unused Portion

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Phosphates Inj, USP 5 mL Vial Label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Phosphates Inj, USP 5 mL Tray Label

NDC 65219-052-29        860529

POTASSIUM

PHOSPHATES

INJECTION, USP

Phosphorus 15 mmol/5 mL

(3 mmol/mL)

Potassium 22 mEq/5 mL

(4.4 mEq/mL)

CAUTION: MUST BE DILUTED

For Intravenous use only

25 x 5 mL

Single-Dose Vials Rx only

Discard Unused Portion

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Phosphates Inj, USP 5 mL Tray Label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Phosphates Inj, USP 15 mL Vial Label

NDC 65219-054-09        860539

POTASSIUM PHOSPHATES

INJECTION, USP

Phosphorus 45 mmol/15 mL

(3 mmol/mL)

Potassium 66 mEq/15 mL

(4.4 mEq/mL)

CAUTION: MUST BE DILUTED

For Intravenous use only

15 mL Single-Dose Vial

Discard Unused Portion Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Phosphates Inj, USP 15 mL Vial Label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Phosphates Inj, USP 15 mL Tray Label

NDC 65219-054-29        860539

POTASSIUM PHOSPHATES

INJECTION, USP

Phosphorus 45 mmol/15 mL

(3 mmol/mL)

Potassium 66 mEq/15 mL

(4.4 mEq/mL)

CAUTION: MUST BE DILUTED

For Intravenous use only

25 x 15 mL

Single-Dose Vials Rx only

Discard Unused Portion

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Phosphates Inj, USP 15 mL Tray Label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Phosphates Inj, USP 50 mL Vial Label

NDC 65219-056-09        860569

POTASSIUM

PHOSPHATES

INJECTION, USP

Phosphorus 150 mmol/50 mL

(3 mmol/mL)

Potassium 220 mEq/50 mL

(4.4 mEq/mL)

Pharmacy Bulk Package –

Not for Direct Infusion

CAUTION: MUST BE DILUTED

For Intravenous use only

50 mL Rx only

Discard Unused Portion

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Phosphates Inj, USP 50 mL Vial Label

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Phosphates Inj, USP 50 mL Tray Label

NDC 65219-056-29        860569

POTASSIUM

PHOSPHATES

INJECTION, USP

Phosphorus 150 mmol/50 mL

(3 mmol/mL)

Potassium 220 mEq/50 mL

(4.4 mEq/mL)

Pharmacy Bulk Package –

Not for Direct Infusion

CAUTION: MUST BE DILUTED

For Intravenous use only

25 x 50 mL

Discard Unused Portion Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Phosphates Inj, USP 50 mL Tray Label