NDC 65219-054

Potassium Phosphates

Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic

Potassium Phosphates is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Potassium Phosphate, Monobasic; Potassium Phosphate, Dibasic.

• Product ID: 65219-054_82fcc1a3-facf-48cb-a366-93596fc0a977
• NDC: 65219-054
• Product Type: Human Prescription Drug
• Proprietary Name: Potassium Phosphates
• Generic Name: Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2020-02-10
• Marketing Category: NDA / NDA
• Application Number: NDA212832
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC
• Active Ingredient Strength: 224 mg/mL; mg/mL
• Pharm Classes: Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 65219-054-29

25 VIAL, SINGLE-DOSE in 1 TRAY (65219-054-29) > 15 mL in 1 VIAL, SINGLE-DOSE (65219-054-09)

• Marketing Start Date: 2020-02-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65219-054-09 [65219005409]

Potassium Phosphates INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: NDA
• Application Number: NDA212832
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2020-02-10

NDC 65219-054-29 [65219005429]

Potassium Phosphates INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: NDA
• Application Number: NDA212832
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2020-02-10

Drug Details

Active Ingredients

Ingredient	Strength
POTASSIUM PHOSPHATE, MONOBASIC	224 mg/mL

OpenFDA Data

• SPL SET ID: 475f5cd7-45bd-412a-b419-9962585d6cda
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 4J9FJ0HL51
  • CI71S98N1Z
• RxNorm Concept Unique ID - RxCUI:
  • 1928569
  • 1928570
  • 1928567
• UPC Code:
  • 0365219056096

Pharmacological Class

• Potassium Compounds [CS]
• Potassium Salt [EPC]
• Osmotic Laxative [EPC]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]
• Potassium Compounds [CS]
• Potassium Salt [EPC]
• Osmotic Laxative [EPC]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]

NDC Crossover Matching brand name "Potassium Phosphates" or generic name "Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic"

NDC	Brand Name	Generic Name
0409-7295	Potassium Phosphates	POTASSIUM PHOSPHATE, MONOBASIC and POTASSIUM PHOSPHATE, DIBASIC
46287-024	POTASSIUM PHOSPHATES	monobasic potassium phosphate and dibasic potassium phosphate
63323-086	Potassium Phosphates	POTASSIUM PHOSPHATE, MONOBASIC and POTASSIUM PHOSPHATE, DIBASIC
65219-052	Potassium Phosphates	Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic
65219-054	Potassium Phosphates	Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic
65219-056	Potassium Phosphates	Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic