Potassium phosphates injection is indicated as a source of phosphorus: in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.
Preparation Potassium phosphates injection is for intravenous infusion into a central or peripheral vein only after dilution . Using aseptic technique, withdraw the required amount from the vial and add to 0.9% Sodium Chloride Injection, USP (normal saline) or 5% Dextrose Injection, USP (D5W). For adults and pediatric patients 12 years of age and older a total volume of 100 mL or 250 mL is recommended. For pediatr...
Potassium Phosphates Injection, USP is a sterile clear, colorless solution supplied as phosphorus 3 mmol/mL and potassium 4.4 mEq/mL as shown: Product Code Unit of Sale Strength Each 1691 NDC 80830-1691-9 Carton containing 10 units Phosphorus 45 mmol/15 mL and Potassium 66 mEq/15 mL NDC 80830-1691-3 15 mL single-dose, polypropylene vial Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. For ...
www.fda.gov/medwatchPotassium phosphates injection is indicated as a source of phosphorus:
Preparation
Table 1: Maximum Recommended Concentration of Potassium Phosphates Injection by Age and Route of Administration (Peripheral vs. Central)
Patient Population | Peripheral Venous Catheter | Central Venous Catheter |
Adults and Pediatric Patients 12 Years of Age and Older | phosphorus 6.8 mmol/100 mL (potassium 10 mEq/100 mL) | phosphorus 18 mmol/100 mL (potassium 26.4 mEq/100 mL) |
Pediatric Patients Less than 12 Years of Age | phosphorus 0.27 mmol/10 mL (potassium 0.4 mEq/10 mL) | phosphorus 0.55 mmol/10 mL (potassium 0.8 mEq/10 mL) |
Administration
Storage and Stability
Potassium phosphates injection provides phosphorus 3 mmol/mL (potassium 4.4 mEq/mL).
The dosage is dependent upon the individual needs of the patient and the contribution of phosphorus and potassium from other sources.
Initial or Single-Dose
The phosphorus doses in Table 2 are general recommendations for an initial or single-dose and are intended for most patients. Based upon clinical requirements, some patients may require a lower or higher dose. The maximum initial or single-dose of phosphorus is 45 mmol (potassium 66 mEq) [see Warnings and Precautions (5.1)].
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 dose range [see Use in Specific Populations (8.6)].
Monitor serum phosphorus, potassium, calcium and magnesium serum concentrations.
Table 2: Recommended Initial or Single-Dose of Potassium Phosphates Injection in Intravenous Fluids to Correct Hypophosphatemia in Adults and Pediatric 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 | potassium 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 | potassium 0.47 mEq/kg to 0.63 mEq/kg |
Less than 1 mg/dL | 0.44 mmol/kg to 0.64 mmol/kgc | potassium 0.64 mEq/kg to 0.94 mEq/kg |
a Serum phosphorus reported using 2.5 mg/dL as the lower end of the reference range for healthy adults and pediatric patients 12 months of age and older. Serum phosphorus reported using 4 mg/dL as the lower end of the reference range for preterm and term infants less than 12 months of age. 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 up to a maximum of phosphorus 45 mmol (potassium 66 mEq) as a single-dose. | ||
Concentration and Intravenous Infusion Rate
Table 3: Maximum Recommended Infusion Rate of Potassium Phosphates Injection for Adults and Pediatric Patients 12 Years of Age and Older
Route of Administration | Maximum Infusion Rate |
Peripheral Venous Catheter | phosphorus 6.8 mmol/hour (potassium 10 mEq/hour) |
Central Venous Catheter | 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:
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.
Storage
Stability
Use parenteral nutrition solution containing potassium phosphates injection promptly after mixing. Any storage of the admixture should be under refrigeration from 2° to 8°C (36° to 46°F) and limited to a brief period of time, no longer than 24 hours. After removal from refrigeration, bring to room temperature and use promptly and complete the infusion within 24 hours. Discard any remaining admixture.
Potassium phosphates injection provides phosphorus 3 mmol/mL (potassium 4.4 mEq/mL).
The recommended daily dosage in parenteral nutrition is shown in Table 4. Individualize the dosage based upon the patient’s clinical condition, nutritional requirements and the contribution of oral or enteral phosphorus and potassium intake. The amount of phosphorus that can be added to parenteral nutrition may be limited by the amount of calcium that is also added to the solution.
Table 4: Recommended Daily Dosage of Potassium Phosphates Injection for Parenteral Nutrition for Adults and Pediatric Patients
Patient Population | Generally Recommended Phosphorus Daily Dosage (Potassium Content) |
Preterm and Term Infants Less than 12 Months | 2 mmol/kg/day (potassium 2.9 mEq/kg/day) |
Pediatric Patients 1 year to Less Than 12 years | 1 mmol/kg/day; up to 40 mmol/day (potassium 1.5 mEq/kg/day; up to 58.7 mEq/day) |
Adults and Pediatric Patients 12 Years of Age and Older | 20 mmol/day to 40 mmol/daya (potassium 29.3 mEq/day to 58.7 mEq/day) |
a 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. | |
Monitoring
Monitor serum phosphorus, potassium, calcium and magnesium concentrations and adjust the dosage accordingly.
Potassium phosphates injection, USP is a sterile clear, colorless solution supplied as:
Potassium phosphates 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 hour to 3 hours) in intravenous fluids has resulted in death, cardiac arrest, cardiac arrhythmia (including QT prolongation), hyperkalemia, hyperphosphatemia and seizures [see Overdosage (10)]. In addition, inappropriate intravenous administration of undiluted or insufficiently diluted potassium phosphates as a rapid “intravenous push” has resulted in cardiac arrest, cardiac arrhythmias, hypotension and death.
Potassium phosphates injection is for intravenous infusion only after dilution or admixing. The maximum initial or single-dose of potassium phosphates injection in intravenous fluids to correct hypophosphatemia is phosphorus 45 mmol (potassium 66 mEq). The recommended infusion rate for administration through a peripheral venous catheter is approximately phosphorus 6.8 mmol/hour (potassium 10 mEq/hour). Continuous electrocardiographic (ECG) monitoring is recommended for higher infusion rates [see Dosage and Administration (2.1, 2.2)].
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 parenteral nutrition infusion and initiate a medical evaluation. In addition to inspection of the solution [see Dosage and Administration (2.3)], the infusion set and catheter should also periodically be checked for precipitates.
Potassium phosphates injection may increase the risk of hyperkalemia, including life-threatening cardiac events, especially when administered in excessive doses, undiluted or by rapid intravenous infusion [see Warnings and Precautions (5.1)]. Patients with severe renal impairment and end stage renal disease are at increased risk of developing life-threatening hyperkalemia, when administered intravenous potassium [see Contraindications (4)]. 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 effects of hyperkalemia.
Consider the amount of potassium from all sources when determining the dose of potassium phosphates injection and do not exceed the maximum age-appropriate recommended daily amount of potassium. 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 dose range and monitor serum potassium, phosphorus, calcium and magnesium concentrations [see Dosage and Administration (2.2, 2.4), Use in Specific Populations (8.6)] .
When administering potassium phosphates injection in intravenous fluids to correct hypophosphatemia, check the serum potassium concentration prior to administration. If the potassium concentration is 4 mEq/dL or more, do not administer potassium phosphates injection and use an alternative source of phosphorus [see Dosage and Administration (2.1)].
The maximum initial or single-dose of potassium phosphates injection in intravenous fluids to correct hypophosphatemia is phosphorus 45 mmol (potassium 66 mEq). The recommended infusion rate of potassium through a peripheral venous catheter is 10 mEq/hour. Continuous electrocardiographic (ECG) monitoring is recommended for higher infusion rates of potassium [see Dosage and Administration (2.2)].
Hyperphosphatemia can occur with intravenous administration of potassium phosphates, especially in patients with renal impairment. 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 injection. Potassium phosphates injection is contraindicated in patients with hyperphosphatemia and/or hypercalcemia [see Contraindications (4)].
Monitor serum phosphorus and calcium concentrations during treatment with potassium phosphates injection [see Dosage and Administration (2.2, 2.4)].
Potassium phosphates injection contains aluminum that may be toxic.
Aluminum may reach toxic levels with prolonged parenteral administration in patients with renal impairment. Preterm infants are particularly at risk for aluminum toxicity because their kidneys are immature and they require large amounts of calcium and phosphate containing solutions, which also contain aluminum.
Patients with renal impairment, including preterm infants, who receive greater than 4 to 5 mcg/kg/day of parenteral aluminum can accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Exposure to aluminum from potassium phosphates injection is no more than 0.6 mcg/kg/day when patients are administered the recommended dosage [see Dosage and Administration (2.4), Description (11)] .
When prescribing potassium phosphates injection for use in parenteral nutrition solutions containing other small volume parenteral products, the total daily patient exposure to aluminum from the admixture should be considered and maintained at no more than 5 mcg/kg/day [see Use in Specific Populations (8.4)] .
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.
Potassium phosphates injection must be diluted and administered in intravenous fluids or used as an admixture in parenteral nutrition. It is not for direct intravenous infusion. 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 in intravenous fluids to correct hypophosphatemia, a generally recommended maximum concentration is phosphorus 6.8 mmol/100 mL (potassium 10 mEq/100 mL) [see Dosage and Administration (2.1)].
Parenteral nutrition solutions with an osmolarity of 900 mOsmol/L or greater must be infused through a central catheter [see Dosage and Administration (2.3)].
Monitor serum phosphorus, potassium, calcium and magnesium concentrations during treatment [see Dosage and Administration (2.2, 2.4)].
The following clinically significant adverse reactions are described elsewhere in the labeling:
The following adverse reactions in Table 5 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.
Table 5: Adverse Reactions Reported in Clinical Studies or Post-marketing Reports with Intravenous Potassium Phosphates
System Organ Class | Adverse Reactions |
Metabolism and Nutrition Disorders | pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.2)], hyperkalemia [see Warnings and Precautions (5.3)], hyperphosphatemia [see Warnings and Precautions (5.4)], hypocalcemia [see Warnings and Precautions (5.5)], hypovolemia and osmotic diuresis |
Cardiac Disorders | hypotension, arrhythmia, heart block, cardiac arrest, bradycardia, chest pain, ECG changes [see Warnings and Precautions (5.1)] and edema |
Respiratory, Thoracic and Mediastinal Disorders | dyspnea [see Warnings and Precautions (5.2)] |
Renal and Urinary Disorders | acute phosphate nephropathy (i.e., nephrocalcinosis with acute kidney injury), decreased urine output and transition to chronic kidney disease [see Warnings and Precautions (5.4)] |
Gastrointestinal Disorders | diarrhea, stomach pain |
Musculoskeletal and Connective Tissue Disorders | weakness |
Nervous System Disorders | confusion, lethargy, paralysis, paresthesia |
Administration of potassium phosphates 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, in particular in the presence of other risk factors for hyperkalemia [see Warnings and Precautions (5.3)]. Avoid use of potassium phosphates injection in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations [see Dosage and Administration (2.2, 2.4)].
Risk Summary
Administration of the recommended dose of potassium phosphates injection is not expected to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with potassium phosphates injection.
The estimated 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. Parenteral supplementation with potassium phosphates should be considered if a pregnant woman’s requirements cannot be fulfilled by oral or enteral intake.
Risk Summary
Phosphorus and potassium are present in human milk. Administration of the recommended dose of potassium phosphates 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 injection and any potential adverse effects on the breastfed child from potassium phosphates injection or from underlying maternal condition.
Safety and effectiveness of potassium phosphates injection have been established in pediatric patients as a source of phosphorus:
Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with potassium phosphates injection may be at higher risk of aluminum toxicity [see Warnings and Precautions (5.5)].
In general, dose selection of potassium phosphates 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 injection may be greater in patients with impaired renal function [see Warnings and Precautions (5.3, 5.4, 5.5)].
Potassium phosphates injection is contraindicated due to the risk of hyperkalemia in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2) or end stage renal disease [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 (2.2, 2.4)].
Hyperphosphatemia
Administration of excessive doses of intravenous potassium phosphates in intravenous fluids as a single-dose ranging from approximately 50 mmol to 270 mmol phosphorus and/or at rapid infusion rates (over 1 hour 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 Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile clear, colorless, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in water for injection. It is supplied as a 15 mL single-dose vial.
Monobasic potassium phosphate, USP is chemically designated potassium dihydrogen phosphate. The molecular formula is KH2PO4, molecular weight is 136.084 g/mol and the structural formula is as below:
It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water and practically insoluble in alcohol.
Dibasic potassium phosphate, USP is chemically designated dipotassium hydrogen phosphate. The molecular formula is K2HPO4, molecular weight is 174.18 g/mol and the structural formula is as below:
It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water.
Each mL of Potassium Phosphates Injection, USP contains monobasic potassium phosphate USP, 224 mg; dibasic potassium phosphate USP, 236 mg and water for injection.
Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0.
This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)].
The osmolarity is 7.4 mOsmol/mL (calc).
The solution is administered after dilution or admixing by the intravenous route.
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.
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 Injection, USP is a sterile clear, colorless solution supplied as phosphorus 3 mmol/mL and potassium 4.4 mEq/mL as shown:
Product Code | Unit of Sale | Strength | Each |
1691 | NDC 80830-1691-9
Carton containing 10 units | Phosphorus 45 mmol/15 mL and Potassium 66 mEq/15 mL | NDC 80830-1691-3 15 mL single-dose, polypropylene vial |
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
For storage of admixed solution, see Dosage and Administration 2.1, 2.3.
Inform patients, caregivers or home healthcare providers of the following risks of potassium phosphates injection:
Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad 382110, INDIA
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Rev. 05-2026-01
Novaplus is a registered trademark of Vizient Inc.
NDC 80830-1691-3
POTASSIUM PHOSPHATES INJECTION, USP
Phosphorus 45 mmol/15 mL (3 mmol/mL)
Potassium 66 mEq/15 mL (4.4 mEq/mL)
15 mL Vial Label
Rx only
Amneal Pharmaceuticals LLC
NDC 80830-1691-9
POTASSIUM PHOSPHATES INJECTION, USP
Phosphorus 45 mmol/15 mL (3 mmol/mL)
Potassium 66 mEq/15 mL (4.4 mEq/mL)
10 x 15 mL Carton Label
Rx only
Amneal Pharmaceuticals LLC
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | DataBar Stacked | (01)00380830169130 | GTIN-14: 00380830169130 GTIN-12: 380830169130 UPC-A: 380830169130 EAN-13: 0380830169130 GTIN storage (14 digits): 00380830169130 | potassium-phosphates-injection-novaplus-4.jpg |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80830-1691-1 | ML - Milliliter | 80830-1691 | eb311358-c9e8-45ba-b950-8bfe75b4fd83 | 1 | 2023-12-05 |
| 80830-1691-2 | ML - Milliliter | 80830-1691 | 5a4c48ea-de13-4cdf-a26d-dbd82861809e | 1 | 2023-12-05 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 80830-1691 | 80830-1691-3, 80830-1691-9 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POTASSIUM PHOSPHATE, MONOBASIC | 4J9FJ0HL51 | ACTIB |
| POTASSIUM PHOSPHATE, DIBASIC | CI71S98N1Z | ACTIB |
| WATER | 059QF0KO0R | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-04-30 | full-release | 2026-05-31 21:51:54 |
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 |
|---|---|---|---|---|---|---|---|
| A216344-001 | POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | |
| A216344-002 | POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | |
| A216344-003 | POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 |
| Application-product | TE code |
|---|---|
| A216344-001 | AP |
| A216344-002 | AP |
| A216344-003 | AP |
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 | A216344-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A216344-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A216344-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A216344-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216344-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216344-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216344-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216344-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216344-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216344-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216344-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216344-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216344-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216344-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216344-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216344-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216344-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216344-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216344-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216344-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216344-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216344-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216344-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216344-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216344-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216344-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216344-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216344-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216344-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216344-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216344-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216344-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216344-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216344-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216344-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216344-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216344-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216344-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216344-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216344-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-10-10 | 301d65b070ca… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A216344-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A216344-002 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A216344-003 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A216344-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216344-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216344-003 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A216344-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216344-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216344-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216344-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216344-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216344-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216344-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216344-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216344-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216344-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216344-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216344-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216344-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216344-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216344-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216344-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216344-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216344-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216344-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216344-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216344-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216344-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216344-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216344-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216344-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216344-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216344-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216344-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216344-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216344-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216344-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216344-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216344-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216344-001 | AP | 1 | 301d65b070ca… |
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 PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION, | Amneal Pharmaceuticals Private Limited | 98315c6e-308d-423b-a046-4be1f54d30ae | 2026-09-01 | Warnings, Adverse reactions | 80830-1691 |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION, | Amneal Pharmaceuticals Private Limited | 125121b8-bc4c-44ee-906e-e72f652a5aa6 | 2026-09-01 | Warnings, Adverse reactions | 80830-1691-3 80830-1691-9 80830-1691 80830169109 80830169103 af2c982a-265f-4101-a024-ea0b7e5722e1 125121b8-bc4c-44ee-906e-e72f652a5aa6 |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION, | Amneal Pharmaceuticals Private Limited | 89136c51-a60b-4269-bd05-9489f060a734 | 2024-12-31 | Warnings, Adverse reactions | 80830-1691 |
Adverse event summaries are temporarily unavailable. Other product information remains available.