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 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...
www.fda.gov/medwatch
www.fresenius-kabi.com/usPotassium 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.
| a Serum phosphorus reported using 2.5 mg/dL as the lower end of the reference range for healthy adults. Serum phosphorus concentrations may vary depending on the assay used and the laboratory reference range. b Weight is in terms of actual body weight. Limited information is available regarding dosing of patients significantly above ideal body weight; consider using an adjusted body weight for these patients. c This single-dose preparation of Potassium Phosphates in Sodium Chloride Injection contains phosphorus 15 mmol and potassium 22 mEq. Additional dose(s) following the initial dose may be needed in some patients. | ||
Serum Phosphorus Concentrationa | Phosphorus Dosageb, c | Corresponding Potassium Content |
1.8 mg/dL to lower end of the reference rangea | 0.16 mmol/kg to 0.31 mmol/kg | 0.23 mEq/kg to 0.46 mEq/kg |
1 mg/dL to 1.7 mg/dL | 0.32 mmol/kg to 0.43 mmol/kg | 0.47 mEq/kg to 0.63 mEq/kg |
Less than 1 mg/dL | 0.44 mmol/kg to 0.64 mmol/kgc | 0.64 mEq/kg to 0.94 mEq/kg |
Concentration and Intravenous Infusion Rate
Selection of the ready-to-use container solution concentration and the infusion rate is dependent upon whether administration will be through a peripheral or central venous catheter. The infusion rate may also be adjusted based on patient characteristics and the specific institution policy.
The maximum recommended concentration and infusion rates for Potassium Phosphates in Sodium Chloride Injection are shown in Table 2 for adults and pediatric patients weighing 40 kg or greater.
Route of Administration | Maximum Concentration | Maximum Infusion Rate |
Peripheral Venous Catheter | Phosphorus 6.8 mmol/100 mL (potassium 10 mEq/100 mL) | Phosphorus 6.8 mmol/hour (potassium 10 mEq/hour) |
Central Venous Catheter | Phosphorus 18 mmol/100 mL (potassium 26.4 mEq/100 mL) | Phosphorus 15 mmol/hour (potassium 22 mEq/hour) |
Continuous electrocardiographic (ECG) monitoring and infusion through a central venous catheter is recommended for infusion rates higher than potassium 10 mEq/hour.
Repeated Dosing
Additional dose(s) following the initial dose may be needed in some patients. Prior to administration of additional doses, assess the patient clinically, obtain serum phosphorus, calcium, and potassium concentrations and adjust the dose accordingly.
Injection:
Potassium Phosphates in Sodium Chloride Injection is contraindicated in patients with:
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)].
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 m2) and dosage adjustment is required for patients with moderate renal impairment (eGFR ≥30 mL/min/1.73 m2 to <60 mL/min/1.73 m2) [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)].
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 formation may also have occurred. If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. In addition to inspection of the solution, the infusion set and catheter should also be checked periodically for precipitates. [see Dosage and Administration (2.1)].
Hyperphosphatemia can occur with intravenous administration of potassium phosphates, especially in patients with renal impairment [see Contraindications (4)]. Hyperphosphatemia can cause the formation of insoluble calcium phosphorus products with consequent hypocalcemia, neurological irritability with tetany, nephrocalcinosis with acute kidney injury, and more rarely, cardiac irritability with arrhythmias.
Obtain serum calcium concentrations prior to administration and normalize the calcium before administering Potassium Phosphates in Sodium Chloride Injection. Potassium Phosphates in Sodium Chloride Injection is contraindicated in patients with hyperphosphatemia and/or hypercalcemia [see Contraindications (4)].
Monitor serum phosphorus and calcium concentrations during treatment with Potassium Phosphates in Sodium Chloride Injection [see Dosage and Administration (2.3)].
Intravenous infusion of phosphate has been reported to cause a decrease in serum magnesium (and calcium) concentrations when administered to patients with hypercalcemia and diabetic ketoacidosis. Monitor serum magnesium concentrations during treatment.
The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral administration is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible and initiate appropriate medical treatment if thrombophlebitis develops.
When administered peripherally to correct hypophosphatemia, a generally recommended maximum concentration is phosphorus 6.8 mmol/100 mL (potassium 10 mEq/100 mL) [see Dosage and Administration (2.2)].
Monitor serum phosphorus, potassium, calcium, and magnesium concentrations during treatment [see Dosage and Administration (2.3)].
The following clinically significant adverse reactions are described elsewhere in the labeling:
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
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)].
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.
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.
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.
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)].
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)].
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 m2) due to the risk of hyperkalemia [see Contraindications (4)].
In patients with moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2), start at the low end of the dosage range and monitor serum potassium, phosphorus, calcium, and magnesium concentrations [see Dosage and Administration (2.4)].
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:
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.
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 KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water.
Dibasic Potassium Phosphate is chemically designated K2HPO4, 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.
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.
The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of potassium phosphates have not been fully characterized.
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.
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.
Inform patients, caregivers, or home healthcare providers of the following risks of Potassium Phosphates in Sodium Chloride Injection:
Manufactured For:
Lake Zurich, IL 60047
Toll free number: 1-800-551-7176
451846
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
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
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
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
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
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
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2716829 | potassium phosphates (phosphorus 15 MMOL / potassium 22 MEQ) in 100 ML Injection | PSN | 2 |
| 2688947 | potassium phosphates (phosphorus 15 MMOL / potassium 22 MEQ) in 250 ML Injection | PSN | 2 |
| 2716829 | 100 ML dibasic potassium phosphate 11.8 MG/ML / monobasic potassium phosphate 11.2 MG/ML Injection | SCD | 2 |
| 2688947 | 250 ML dibasic potassium phosphate 4.72 MG/ML / monobasic potassium phosphate 4.48 MG/ML Injection | SCD | 2 |
| 2716829 | 100 ML dibasic K+ phosphate 11.8 MG/ML / monobasic K+ phosphate 11.2 MG/ML Injection | SY | 2 |
| 2716829 | 100 ML dibasic Pot phosphate 11.8 MG/ML / monobasic Pot phosphate 11.2 MG/ML Injection | SY | 2 |
| 2688947 | 250 ML dibasic K+ phosphate 4.72 MG/ML / monobasic K+ phosphate 4.48 MG/ML Injection | SY | 2 |
| 2688947 | 250 ML dibasic Pot phosphate 4.72 MG/ML / monobasic Pot phosphate 4.48 MG/ML Injection | SY | 2 |
| 2716829 | phosphorus 15 MMOL / potassium 22 MEQ per 100 ML Injection | SY | 2 |
| 2688947 | phosphorus 15 MMOL / potassium 22 MEQ per 250 ML Injection | SY | 2 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65219-656-01 | Potassium Phosphates | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | 2 | |
| 65219-656-01 | Potassium Phosphates | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | 2 | |
| 65219-656-10 | Potassium Phosphates | 24 in 1 CARTON | INJECTION, SOLUTION | 24 | 2 | |
| 65219-658-01 | Potassium Phosphates | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | 2 | |
| 65219-658-01 | Potassium Phosphates | 250 mL in 1 BAG | INJECTION, SOLUTION | 250 | 2 | |
| 65219-658-25 | Potassium Phosphates | 30 in 1 CARTON | INJECTION, SOLUTION | 30 | 2 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65219-656-01 | ML - Milliliter | 65219-656 | 42a8a00d-b276-48be-9b7e-7d8177329e27 | 1 | 2025-07-08 |
| 65219-656-10 | ML - Milliliter | 65219-656 | 226f2a42-f91a-4665-8e10-540f9ca06df0 | 1 | 2025-07-08 |
| 65219-658-01 | ML - Milliliter | 65219-658 | ab724b2a-6449-485f-afe3-7d7421b18220 | 1 | 2025-07-08 |
| 65219-658-25 | ML - Milliliter | 65219-658 | 5059f7e4-e6c1-40d1-b076-fb357cc95b9d | 1 | 2025-07-08 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65219-656 | 65219-656-01, 65219-656-10 |
| 65219-658 | 65219-658-01, 65219-658-25 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MONOBASIC POTASSIUM PHOSPHATE | 4J9FJ0HL51 | ACTIB |
| DIBASIC POTASSIUM PHOSPHATE | CI71S98N1Z | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| WATER | 059QF0KO0R | IACT |
| MONOBASIC POTASSIUM PHOSPHATE | 4J9FJ0HL51 | ACTIB |
| DIBASIC POTASSIUM PHOSPHATE | CI71S98N1Z | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| WATER | 059QF0KO0R | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N212832-001 | POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 |
| N212832-002 | POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 |
| N212832-003 | POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 |
| N212832-004 | POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-05-09 | |
| N212832-005 | POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-05-09 |
| Application-product | TE code |
|---|---|
| N212832-001 | AP |
| N212832-002 | AP |
| N212832-003 | AP |
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N212832-004 | 11813291 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 |
| N212832-004 | 11925661 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 |
| N212832-005 | 11813291 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 |
| N212832-005 | 11925661 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N212832-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212832-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212832-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212832-004 | POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | 1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-05-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212832-005 | POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-05-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N212832-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212832-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212832-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212832-004 | POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | 1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-05-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212832-005 | POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-05-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N212832-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N212832-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N212832-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N212832-004 | POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | 1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-05-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N212832-005 | POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-05-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212832-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212832-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212832-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212832-004 | POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | 1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-05-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212832-005 | POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-05-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212832-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML(236MG/ML); 1.12GM/5ML(224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N212832-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML(236MG/ML); 3.36GM/15ML(224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N212832-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML(236MG/ML); 11.2GM/50ML(224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N212832-004 | POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | 1.18GM/100ML(11.8MG/ML); 1.12GM/100ML(11.2MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-05-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212832-005 | POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | 1.18GM/250ML(4.72MG/ML); 1.12GM/250ML(4.48MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2025-05-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212832-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212832-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212832-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212832-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212832-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212832-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212832-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212832-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212832-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212832-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212832-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212832-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212832-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212832-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212832-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2019-11-26 | 5bbf6a4d5a75… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N212832-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212832-002 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212832-003 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N212832-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212832-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212832-003 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N212832-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N212832-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N212832-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212832-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212832-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212832-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N212832-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N212832-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N212832-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212832-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212832-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212832-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212832-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212832-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212832-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212832-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212832-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212832-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212832-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212832-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212832-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212832-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212832-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212832-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212832-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212832-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212832-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N212832-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N212832-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N212832-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212832-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212832-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212832-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212832-001 | AP | 1 | 301d65b070ca… |
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N212832-004 | 11813291 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212832-004 | 11925661 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212832-005 | 11813291 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212832-005 | 11925661 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N212832-004 | 11813291 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212832-004 | 11925661 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212832-005 | 11813291 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212832-005 | 11925661 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N212832-004 | 11813291 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N212832-004 | 11925661 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N212832-005 | 11813291 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N212832-005 | 11925661 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212832-004 | 11813291 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212832-004 | 11925661 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212832-005 | 11813291 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212832-005 | 11925661 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N212832-004 | 11813291 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N212832-004 | 11925661 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N212832-005 | 11813291 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N212832-005 | 11925661 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212832-004 | 11813291 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212832-004 | 11925661 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212832-005 | 11813291 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212832-005 | 11925661 | 2041-10-12 | U-4185 | Drug product | 2025-05-22 | a50c72e98297… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Potassium Phosphates | POTASSIUM PHOSPHATES | Fresenius Kabi USA, LLC | 357c3020-ea6f-4401-a2e7-cebb82b03144 | 2025-04-15 | Warnings, Adverse reactions | 65219-656-10 65219-658-25 65219-658-01 65219-656-01 65219-658 65219-656 65219065825 65219065610 65219065801 65219065601 b813e96f-27c8-4bb1-ba28-6319ee823a14 357c3020-ea6f-4401-a2e7-cebb82b03144 |
Adverse event summaries are temporarily unavailable. Other product information remains available.