Potassium Phosphates 4.48 mg/mL; 4.72 mg/mL Injection, Solution — NDC 65219-658-25 (Billing 65219-0658-25)
This is a package of Potassium Phosphates 4.48 mg/mL; 4.72 mg/mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 066998
- GCN: 29444
- GPI-14 (Medi-Span): 79600010102025
- HICL (First Databank): 037356
- AHFS class code: 40:12.00.00
- RxCUI (RxNorm): 2688947
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
- Great question. This IV form is used when your phosphate levels are too low to safely wait for a pill to work, or when you're not able to eat or take anything by mouth right now. I...
- Why am I getting this through an IV instead of just taking a phosphorus pill?
- It depends on how serious your kidney issues are. If you have severe kidney disease or are on dialysis, this specific product cannot be used — your kidneys would struggle to clear...
- Is it safe to get this if I have kidney problems?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 65219-0658-25 You're viewing this Main listing | 30 POUCH in 1 CARTON / 1 BAG in 1 POUCH / 250 mL in 1 BAG | 2025-06-15 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Potassium Phosphates 4.48 mg/mL; 4.72 mg/mLthis 65219-0658-25 | Fresenius | 30 pouches | — | — | FDA listed | — |
| Potassium Phosphates 4.48 mg/mL; 4.72 mg/mL 70121-1722-09 | Amneal | 24 pouches | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11925661 ↗ | Method of use | U-4185 | Oct 12, 2041 |
| US 11925661 ↗ | Method of use | U-4185 | Oct 12, 2041 |
| US 11813291 ↗ | Method of use | U-4185 | Oct 12, 2041 |
| US 11813291 ↗ | Method of use | U-4185 | Oct 12, 2041 |
Is there a generic version of POTASSIUM PH 15 MMOL/250 ML-NS?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
9 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated. Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Important Preparation Instructions • Do NOT dilute prior to administration. ( 2.1 ) • Use this potassium phosphates in sodium chloride injection product only in patients who require the entire 15 mmoL phosphorus dose (potassium 22 mEq) and not any fraction thereof. If the entire 15 mmol phosphorus dose is not required, consider an alternative formulation of potassium phosphate.
( 2.1 ) Important Administration Instructions • Potassium Phosphates in Sodium Chloride Injection is only for administration to a patient with a serum potassium concentration less than 4 mEq/dL; otherwise, use an alternative source of phosphorus. ( 2.2 ) • This product contains phosphorus 15 mmol and potassium 22 mEq. ( 2.2 ) o The 100 mL ready-to-use container is for intravenous infusion into a central vein. o The 250 mL ready-to-use container is for intravenous infusion into a central or peripheral vein.
Recommended Dosage • See full prescribing information for recommendations on initial or single dosing, repeated dosing, concentration and infusion rate. ( 2.3 ) • Monitor serum phosphorus, potassium, calcium, and magnesium concentrations. ( 2.3 ) • Patients with moderate renal impairment should start at the low end of the dosage range.
Potassium Phosphates in Sodium Chloride Injection is contraindicated in patients with severe renal impairment. ( 2.4 , 4 )
2.1Important Preparation Instructions • Potassium Phosphates in Sodium Chloride Injection is for intravenous infusion into a central or peripheral vein. Do NOT dilute prior to administration. • Use this potassium phosphates in sodium chloride injection product only in patients who require the entire 15 mmoL phosphorus dose (potassium 22 mEq) and not any fraction thereof. • If a dose of potassium phosphate is required that does not equal 15 mmoL of Potassium phosphates in Sodium Chloride Injection, then an alternative formulation of potassium phosphates should be considered. • Visually inspect the solution for particulate matter and discoloration prior to administration.
Do not administer unless solution is clear, and the seal of the container is intact. • Always inspect the solution container before and after removal from the overwrap. • Place the solution container on a clean, flat surface. Remove the solution container from the overwrap. • Check the solution container for leaks by squeezing firmly. Discard if leaks are found. • Immediately before inserting the infusion set, remove the twist-off infusion port. • Use a non-vented infusion set or close the air-inlet on a vented set. • Close the roller clamp of the infusion set. • Hold the base of the twist-off infusion port, twist and push the spike until fully inserted.
The infusion port is not intended to be spiked more than once. • Suspend the solution container from the hanger hole. • For single-dose only. Discard any unused portion.
2.2Important Administration Instructions • Check serum potassium and calcium concentrations prior to administration. Normalize the calcium before administering Potassium Phosphates in Sodium Chloride Injection [see Contraindications ( 4 ), Warnings and Precautions ( 5.3 , 5.4 )] . • Potassium Phosphates in Sodium Chloride Injection is only for administration to a patient with a serum potassium concentration less than 4 mEq/dL [see Warnings and Precautions ( 5.3 )] . If the potassium concentration is 4 mEq/dL or more, use an alternative source of phosphorus. • Do not infuse with calcium-containing intravenous fluids [see Warnings and Precautions ( 5.4 )] . • The 100 mL ready-to-use container of this Potassium Phosphates in Sodium Chloride Injection product contains phosphorus 15 mmol (phosphorus 0.15 mmol/mL) and potassium 22 mEq (potassium 0.22 mEq/mL) and is for intravenous infusion into a central vein . • The 250 mL ready-to-use container of this Potassium Phosphates in Sodium Chloride Injection product contains phosphorus 15 mmol and potassium 22 mEq (phosphorus 0.06 mmol/mL and potas… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: • phosphorus 15 mmol/100 mL (0.15 mmol/mL) and potassium 22 mEq/100 mL (0.22 mEq/mL) in a clear, colorless solution in a ready-to-use, single-dose container. • phosphorus 15 mmol/250 mL (0.06 mmol/mL) and potassium 22 mEq/250 mL (0.088 mEq/mL) in a clear, colorless solution in a ready-to-use, single-dose container. Injection: • phosphorus 15 mmol/100 mL (0.15 mmol/mL) and potassium 22 mEq/100 mL (0.22 mEq/mL) in a single-dose container. Ready-to-use.
( 3 ) • phosphorus 15 mmol/250 mL (0.06 mmol/mL) and potassium 22 mEq/250 mL (0.088 mEq/mL) in a single-dose container. Ready-to-use. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Potassium Phosphates in Sodium Chloride Injection is contraindicated in patients with: • hyperkalemia [see Warning and Precautions ( 5.2 )] • hyperphosphatemia [see Warning and Precautions ( 5.4 )] • hypercalcemia or significant hypocalcemia [see Warning and Precautions ( 5.4 )] • severe renal impairment (eGFR less than 30 mL/min/1.73m 2 ) [see Warning and Precautions ( 5.2 )] • hyperkalemia ( 4 ) • hyperphosphatemia ( 4 ) • hypercalcemia or significant hypocalcemia ( 4 ) • severe renal impairment (eGFR less than 30 mL/min/1.73m 2 ) ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Serious Cardiac Adverse Reactions with Bolus, or Rapid Intravenous Administration : Do not exceed the recommended infusion rate. Continuous electrocardiographic (ECG) monitoring may be needed during infusion. ( 2.3 , 5.1 ) • Hyperkalemia : Increased risk in patients with renal impairment, severe adrenal insufficiency, or treated with drugs that increase potassium.
Patients with cardiac disease may be more susceptible. Do not exceed the maximum daily amount of potassium or the recommended infusion rate. Continuous ECG monitoring may be needed during infusion.
( 5.2 , 7.1 ) • Pulmonary Embolism due to Pulmonary Vascular Precipitates : If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.3 ) • Hyperphosphatemia and Hypocalcemia : Monitor serum phosphorus and calcium concentrations during and following infusion. ( 5.4 ) • Hypomagnesemia : Reported in patients with hypercalcemia and diabetic ketoacidosis.
Monitor serum magnesium concentrations during treatment. ( 5.5 ) • Vein Damage and Thrombosis : Infuse hypertonic solutions through a central catheter. ( 2.1 , 5.6 )
5.1Serious Cardiac Adverse Reactions with Bolus or Rapid Intravenous Administration Intravenous administration of potassium phosphates to correct hypophosphatemia in single-doses of phosphorus 50 mmol and greater and/or at rapid infusion rates (over 1 to 3 hours) has resulted in death, cardiac arrest, cardiac arrhythmia (including QT prolongation), hyperkalemia, hyperphosphatemia, and seizures [see Overdosage ( 10 )] . Continuous electrocardiographic (ECG) monitoring is recommended for infusion rates higher than potassium 10 mEq/hour [see Dosage and Administration ( 2.1 , 2.2 )] .
5.2Hyperkalemia Potassium Phosphates in Sodium Chloride Injection may increase the risk of hyperkalemia, including life-threatening cardiac events, especially when administered in excessive doses or by rapid intravenous infusion [see Warnings and Precautions ( 5.1 )] . Patients with renal impairment and are at increased risk of developing life-threatening hyperkalemia, when administered intravenous potassium. Potassium Phosphates in Sodium Chloride Injection is contraindicated in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ) and dosage adjustment is required for patients with moderate renal impairment (eGFR ≥30 mL/min/1.73 m 2 to <60 mL/min/1.73 m 2 ) [see Dosage and Administration ( 2.2 ), Contraindications ( 4 ), Use in Specific Populations ( 8.6 )] .
Other patients at increased risk of hyperkalemia include those with severe adrenal insufficiency or treated concurrently with other drugs that cause or increase the risk of hyperkalemia [see Drug Interactions ( 7.1 )] . Patients with cardiac disease may be more susceptible to the adverse effects of hyperkalemia. Consider the amount of potassium from all sources when determining the dose of Potassium Phosphates in Sodium Chloride Injection and do not exceed the maximum age-appropriate recommended daily amount of potassium.
When administering Potassium Phosphates in Sodium Chloride Injection to correct hypophosphatemia, check the serum potassium concentration prior to administration [see Dosage and Administration ( 2.2 )] . Continuous electrocardiographic (ECG) monitoring is recommended for infusion rates higher than 10 mEq/hour [see Warnings and Precautions ( 5.1 ), Dosage and Administration ( 2.3 )] .
5.3Pulmonary Embolism due to Pulmonary Vascular Precipitates Pulmonary vascular emboli and pulmonary distress related to precipitates in the pulmonary vasculature have been described in patients receiving admixed products containing calcium and phosphate or parenteral nutrition. The cause of precipitate formation has not been determined in all cases; however, in some fatal cases, pulmonary emboli occurred as a result of calcium phosphate precipitates. Precipitation has occurred following passage through an in-line filter; in vivo precipitate fo… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Cardiac Adverse Reactions with Bolus or Rapid Intravenous Administration [see Warnings and Precautions ( 5.1 )] • Hyperkalemia [see Warnings and Precautions ( 5.2 )] • Pulmonary Embolism due to Pulmonary Vascular Precipitates [see Warnings and Precautions ( 5.3 )] • Hyperphosphatemia and Hypocalcemia [see Warnings and Precautions ( 5.4 )] • Hypomagnesemia [see Warnings and Precautions ( 5.5 )] • Vein Damage and Thrombosis [see Warnings and Precautions ( 5.6 )] The following adverse reactions have been reported in clinical studies or post-marketing reports in patients receiving intravenously administered potassium phosphates.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Metabolism and Nutrition Disorders: hyperkalemia, hyperphosphatemia, hypocalcemia, hypovolemia, osmotic diuresis, pulmonary embolism Cardiac Disorders: arrhythmia, bradycardia, cardiac arrest, chest pain, ECG changes, edema, heart block, hypotension Respiratory, Thoracic, and Mediastinal Disorders: dyspnea Renal and Urinary Disorders: acute phosphate nephropathy (i.e., nephrocalcinosis with acute kidney injury), decreased urine output, transition to chronic kidney disease Gastrointestinal Disorders: diarrhea, stomach pain Musculoskeletal and Connective Tissue Disorders: weakness Nervous System Disorders: confusion, lethargy, paralysis, paresthesia Adverse reactions include hyperkalemia, hyperphosphatemia, hypocalcemia, and hypomagnesemia.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Use of Other Medications that Increase Potassium : Avoid use in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations. ( 5.2 , 7.1 )
7.1Other Products that Increase Serum Potassium Administration of Potassium Phosphates in Sodium Chloride Injection to patients treated concurrently or recently with products that increase serum potassium (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, digoxin, or the immunosuppressants tacrolimus and cyclosporine) increases the risk of severe and potentially fatal hyperkalemia, especially in the presence of other risk factors for hyperkalemia [see Warnings and Precautions ( 5.2 )] .
Avoid use of Potassium Phosphates in Sodium Chloride Injection in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations [see Dosage and Administration ( 2.3 )] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Administration of the recommended dose of Potassium Phosphates in Sodium Chloride Injection is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider intravenous potassium phosphate replacement if correction of hypophosphatemia via the enteral route is not possible (see Clinical Considerations ). Animal reproduction studies have not been conducted with Potassium Phosphates in Sodium Chloride Injection.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Phosphorus is an essential mineral element. Intravenous replacement with potassium phosphate should be considered if a pregnant woman requires intravenous replacement to correct hypophosphatemia when the enteral route is not possible, insufficient, or contraindicated.
8.2Lactation Risk Summary Phosphorus and potassium are present in human milk. Administration of the recommended dose of Potassium Phosphates in Sodium Chloride Injection is not expected to cause harm to a breastfed infant. There is no information on the effects of potassium phosphates on milk production.
The development and health benefits of breastfeeding should be considered along with the mother's clinical need for Potassium Phosphates in Sodium Chloride Injection and any potential adverse effects on the breastfed child from Potassium Phosphates in Sodium Chloride Injection or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness of Potassium Phosphates in Sodium Chloride Injection have been established in pediatric patients weighing 40 kg or more as a source of phosphorus to correct hypophosphatemia when oral or enteral replacement is not possible, insufficient, or contraindicated. This Potassium Phosphates in Sodium Chloride Injection product is not approved for use in pediatric patients who weigh less than 40 kg because they would require only a fraction of the ready-to-use container [see Dosage and Administration ( 2.1 )].
8.5Geriatric Use In general, dose selection of Potassium Phosphates in Sodium Chloride Injection for an elderly patient should be cautious, starting at the low end of the dosing range because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. It may be useful to monitor renal function during treatment [see Use in Specific Populations ( 8.6 )] .
8.6Renal Impairment Potassium and phosphorus are known to be substantially excreted by the kidney and the risk of adverse reactions to Potassium Phosphates in Sodium Chloride Injection may be greater in patients with impaired renal function [see Warnings and Precautions ( 5.2 , 5.4 )] . Potassium Phosphates in Sodium Chloride Injection is contraindicated in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ) due to the risk of hyperkalemia [see Contraindications ( 4 )] . In patients with moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m 2 to < 60 mL/min/1.73 m 2 ), start at the low end of the dosage range and monitor serum potassium, phosphorus, calcium, and magnesium concentrations [see Dosage and Administration ( 2.4 )] .
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Administration of the recommended dose of Potassium Phosphates in Sodium Chloride Injection is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider intravenous potassium phosphate replacement if correction of hypophosphatemia via the enteral route is not possible (see Clinical Considerations ). Animal reproduction studies have not been conducted with Potassium Phosphates in Sodium Chloride Injection.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Phosphorus is an essential mineral element. Intravenous replacement with potassium phosphate should be considered if a pregnant woman requires intravenous replacement to correct hypophosphatemia when the enteral route is not possible, insufficient, or contraindicated.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of Potassium Phosphates in Sodium Chloride Injection have been established in pediatric patients weighing 40 kg or more as a source of phosphorus to correct hypophosphatemia when oral or enteral replacement is not possible, insufficient, or contraindicated. This Potassium Phosphates in Sodium Chloride Injection product is not approved for use in pediatric patients who weigh less than 40 kg because they would require only a fraction of the ready-to-use container [see Dosage and Administration ( 2.1 )].
🧓 Geriatric Use ▾
8.5Geriatric Use In general, dose selection of Potassium Phosphates in Sodium Chloride Injection for an elderly patient should be cautious, starting at the low end of the dosing range because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. It may be useful to monitor renal function during treatment [see Use in Specific Populations ( 8.6 )] .
🆘 Overdosage ▾
10 OVERDOSAGE Hyperphosphatemia Administration of excessive doses of intravenous potassium phosphates as a single dose ranging from approximately 50 to 270 mmol phosphorus and/or at rapid infusion rates (over 1 to 3 hours) has resulted in death, cardiac arrest, cardiac arrhythmia (including QT prolongation), hyperkalemia, hyperphosphatemia, seizures, and tetany. Hyperphosphatemia is particularly a risk in patients with renal failure. Hyperphosphatemia leads in turn to hypocalcemia, which may be severe, and to ectopic calcification, particularly in patients with initial hypercalcemia.
Tissue calcification may cause hypotension and organ damage and result in acute renal failure. Hyperkalemia Excessive administration of phosphates given as potassium salts may also cause hyperkalemia. Manifestations of hyperkalemia include: • Disturbances in cardiac conduction and arrhythmias, including bradycardia, heart block, asystole, ventricular tachycardia, ventricular fibrillation, and death. • Hypotension. • Muscle weakness including paresthesia, muscular and respiratory paralysis.
Management In the event of overdosage, discontinue infusions containing potassium phosphates immediately and institute general supportive measures, including ECG monitoring, laboratory monitoring, and correction of serum electrolyte concentrations, especially potassium, phosphorus, calcium, and magnesium.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Phosphorus in the form of organic and inorganic phosphate has a variety of biochemical functions in all organs and tissues, including critical roles in nucleic acid structure, energy storage and transfer, cell signaling, cell membrane composition and structure, acid-base balance, mineral homeostasis, and bone mineralization.
12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of potassium phosphates have not been fully characterized.
12.3Pharmacokinetics Distribution Approximately 85% of serum phosphates is free and ultra-filterable and 15% is protein-bound. Elimination Intravenously infused phosphates not taken up by the tissues are excreted almost entirely in the urine. Serum phosphorus is believed to be filterable by the renal glomeruli, and the major portion of filtered phosphorus (greater than 80%) is actively reabsorbed by the tubules.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Phosphorus in the form of organic and inorganic phosphate has a variety of biochemical functions in all organs and tissues, including critical roles in nucleic acid structure, energy storage and transfer, cell signaling, cell membrane composition and structure, acid-base balance, mineral homeostasis, and bone mineralization.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Phosphates in Sodium Chloride Injection is a clear, colorless solution supplied as: Unit of Sale Strength Each Unit NDC 65219-656-10 Box containing 24 units Phosphorus 15 mmol/100 mL (0.15 mmol/mL) and Potassium 22mEq/100 mL (0.22 mEq/mL) NDC 65219-656-01 100 mL single-dose container NDC 65219-658-25 Box containing 30 units Phosphorus 15 mmol/250 mL (0.06 mmol/mL) and Potassium 22mEq/250 mL (0.088 mEq/mL) NDC 65219-658-01 250 mL single-dose container The container closure is not made with natural rubber latex.
Non-PVC, Non-DEHP, Sterile. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Product should be used within 60 days of removal from overwrap.
Each ready-to-use infusion container contains no preservatives. Do NOT dilute prior to use. Discard any unused portion in the single-dose container immediately.
📋 Description ▾
11 DESCRIPTION Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product. It is a sterile, non-pyrogenic, solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in sodium chloride. It is supplied as a 100 mL and 250 mL ready-to-use single dose container for intravenous use and does not require further dilution.
Monobasic Potassium Phosphate is chemically designated KH 2 PO 4 , molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K 2 HPO 4, molecular weight 174.18, colorless or white granular salt freely soluble in water. For 100 mL single-dose container: Each mL contains 11.2 mg of monobasic potassium phosphate and 11.8 mg of dibasic potassium phosphate.
Each mL contains 0.15 mmol phosphorus (equivalent to 4.65 mg phosphorus), and 0.22 mEq potassium (equivalent to 8.50 mg of potassium). For 250 mL single-dose container: Each mL contains 4.48 mg of monobasic potassium phosphate and 4.72 mg of dibasic potassium phosphate. Each mL contains 0.06 mmol phosphorus (equivalent to 1.86 mg phosphorus), and 0.088 mEq potassium (equivalent to 3.40 mg of potassium).
Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. In addition, each mL of solution contains 9 mg sodium chloride for isotonicity. The pH is 6.0 to 7.0.
This product contains no more than 100 mcg/L of aluminum. The osmolality is 500-700 mOsmol/kg for the 100 mL single-dose container and 300-500 mOsmol/kg for the 250 mL single-dose container.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Inform patients, caregivers, or home healthcare providers of the following risks of Potassium Phosphates in Sodium Chloride Injection: • Advise patients of the serious cardiac risks (e.g., death, cardiac arrest, cardiac arrhythmia, hyperkalemia, hyperphosphatemia, and seizures) associated with rapid administration of Potassium Phosphate in Sodium Chloride Injection [see Warnings and Precautions ( 5.1 )] . • Advise patients that Potassium Phosphate in Sodium Chloride Injection may increase the risk of hyperkalemia when administered in excessive doses or by rapid intravenous infusion [see Warnings and Precautions ( 5.2 )]. • Advise patients that hyperphosphatemia can occur, especially in patients with renal impairment, which can result in hypocalcemia [see Warnings and Precautions ( 5.4 )]. • Advise patients that Potassium Phosphate in Sodium Chloride Injection has been reported to cause hypomagnesemia when administered to patients with hypercalcemia and diabetic ketoacidosis [see Warnings and Precautions ( 5.5 )].
Manufactured For: Lake Zurich, IL 60047 Toll free number: 1-800-551-7176 www.fresenius-kabi.com/us 451846 potsod-img-01.jpg
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Distribution Approximately 85% of serum phosphates is free and ultra-filterable and 15% is protein-bound. Elimination Intravenously infused phosphates not taken up by the tissues are excreted almost entirely in the urine. Serum phosphorus is believed to be filterable by the renal glomeruli, and the major portion of filtered phosphorus (greater than 80%) is actively reabsorbed by the tubules.
📄 Recent Major Changes ▾
Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.4 ) 4/2025 Warnings and Precautions ( 5.1 ) 4/2025
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL – 100 mL Container NDC 65219- 656 -01 Do Not Dilute 100 mL POTASSIUM PHOSPHATES in 0.9% Sodium Chloride Injection Phosphorus 15 mmol/100 mL (0.15 mmol/mL) Potassium 22 mEq/100 mL (0.22 mEq/mL) For Intravenous Use Only Rx Only 100 mL Single-Dose Container Discard Unused Portion potsod-label-01.jpg
PRINCIPAL DISPLAY PANEL – 100 mL Overwrap NDC 65219- 656 -01 Do Not Dilute 1 X 100 mL POTASSIUM PHOSPHATES in 0.9% Sodium Chloride Injection Phosphorus 15 mmol/100 mL (0.15 mmol/mL) Potassium 22 mEq/100 mL (0.22 mEq/mL) For Intravenous Use Only Rx Only 100 mL Single-Dose Container Discard Unused Portion potsod-label-02.jpg
PRINCIPAL DISPLAY PANEL – 100 mL Carton LBL NDC 65219- 656 -10 Do Not Dilute 24 X 100 mL Single-Dose Containers POTASSIUM PHOSPHATES in 0.9% Sodium Chloride Injection Phosphorus 15 mmol/100 mL (0.15 mmol/mL) Potassium 22 mEq/100 mL (0.22 mEq/mL) For Intravenous Use Only Rx Only potsod-label-03.jpg
PRINCIPAL DISPLAY PANEL – 250 mL Container NDC 65219- 658 -01 Do Not Dilute 250 mL POTASSIUM PHOSPHATES in 0.9% Sodium Chloride Injection Phosphorus 15 mmol/250 mL (0.06 mmol/mL) Potassium 22 mEq/250 mL (0.088 mEq/mL) For Intravenous Use Only Rx Only 250 mL Single-Dose Container Discard Unused Portion potsod-label-04.jpg
PRINCIPAL DISPLAY PANEL – 250 mL Overwrap NDC 65219- 658 -01 Do Not Dilute 1 X 250 mL POTASSIUM PHOSPHATES in 0.9% Sodium Chloride Injection Phosphorus 15 mmol/250 mL (0.06 mmol/mL) Potassium 22 mEq/250 mL (0.088 mEq/mL) For Intravenous Use Only Rx Only 250 mL Single-Dose Container Discard Unused Portion potsod-label-05.jpg
PRINCIPAL DISPLAY PANEL – 250 mL Carton LBL NDC 65219- 658 -25 Do Not Dilute 30 X 250 mL Single-Dose Containers POTASSIUM PHOSPHATES in 0.9% Sodium Chloride Injection Phosphorus 15 mmol/250 mL (0.06 mmol/mL) Potassium 22 mEq/250 mL 0.088 mEq/mL) For Intravenous Use Only Rx Only potsod-label-06.jpg
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |