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Potassium Phosphate 224 mg/mL; 236 mg/mL Injection, Solution — NDC 70069-0747-25 package photo
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Potassium Phosphate 224 mg/mL; 236 mg/mL Injection, Solution — NDC 70069-747-25 (Billing 70069-0747-25)

by Somerset Therapeutics, LLC · 25 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE

This is a package of Potassium Phosphate 224 mg/mL; 236 mg/mL Injection, Solution from Somerset Therapeutics, LLC, marketed since Jul 2024 and currently FDA-listed. It is this product's only package size.

NDC 70069-0747-25
🏷️ FDA NDC (as labeled) 70069-747-25 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70069-747-25
Product NDC 70069-747
11-digit billing NDC 70069074725
NCPDP billing unit ML — per mL (volume)
RxCUI 1928567, 1928569
UNII 4J9FJ0HL51, CI71S98N1Z
UPC 0370069747254, 0370069746257, 0370069747018, 0370069746011
Application # ANDA217726
SPL Set ID 52f07402-1869-4a97-9c92-9729dc611f85
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-07-11
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 79600010052030
GCN Seq No 001285
GCN 03591
HICL code 000551
Ingredient (HICL) Potassium Phos,M-Basic-D-Basic
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1P
Therapeutic class — specific (HIC3) Phosphate Replacement
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name POTASSIUM PHOSP 45 MMOL/15 ML
FDB brand name Potassium Phosphate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001285
  • GCN: 03591
  • GPI-14 (Medi-Span): 79600010052030
  • HICL (First Databank): 000551
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 1928567
Why two NDCs? The FDA registers this code as 70069-747-25 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 70069-0747-25. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name POTASSIUM PHOSP 45 MMOL/15 ML Ingredient Potassium Phos,M-Basic-D-Basic
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $5.82 $2,182.13 / 375 ml
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?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70069-0747-25 You're viewing this Main listing 25 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE 2024-07-11 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Potassium Phosphates 224 mg/mL; 236 mg/mL 00409-0032-01 Hospira, 25 vials — AP FDA listed —
Potassium Phosphates 224 mg/mL; 236 mg/mL 00517-2102-25 American 25 vials — AP FDA listed —
Potassium Phosphates 224 mg/mL; 236 mg/mL 65145-0195-25 Caplin 25 vials — AP FDA listed —
Potassium Phosphates 224 mg/mL; 236 mg/mL 65219-0054-29 Fresenius 25 vials — AP FDA listed —
Potassium Phosphates 224 mg/mL; 236 mg/mL 68462-0787-25 GLENMARK 25 vials — AP FDA listed —
Potassium Phosphates 224 mg/mL; 236 mg/mL 69097-0077-97 Cipla 25 vials — AP FDA listed —
Potassium Phosphate 224 mg/mL; 236 mg/mLthis 70069-0747-25 Somerset 25 bottles — AP FDA listed —
Potassium Phosphates 224 mg/mL; 236 mg/mL 72572-0232-25 CIVICA, 25 vials — AP FDA listed —
Potassium Phosphates 224 mg/mL; 236 mg/mL 80830-1691-02 Amneal 10 vials — AP FDA listed —
Potassium Phosphate 224 mg/mL; 236 mg/mL 70069-0746-25 Somerset 25 bottles — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Jul 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSomerset Therapeutics, LLC
Application holderSOMERSET THERAPEUTICS LLC
FDA applicationANDA217726 (ANDA)
Labeler code70069
First marketedJul 2024
Product typeHuman Prescription Drug
Portfolio184 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 112 words ▾

1 INDICATIONS AND USAGE 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. Potassium Phosphates Injection is a phosphorus replacement product 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.

(1) for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer intravenously only after dilution or admixing in a larger volume of fluid. (2.1) Potassium Phosphates Injection provides phosphorus 3 mmol/mL (potassium 4.4 mEq/mL). (2.2, 2.4) Monitor serum phosphorus, potassium, calcium, and magnesium concentrations.

(2.2, 2.4) See full prescribing information for instructions on preparation and administration. (2.1, 2.3) Recommended Dosage for Correction of Hypophosphatemia in Intravenous Fluids Potassium Phosphates 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. (2.1) The dosage is dependent upon the individual needs of the patient, and the contribution of phosphorus and potassium from other sources.

(2.2) See full prescribing information for recommendations on initial or single dosing, repeated dosing, concentration and infusion rate. (2.1, 2.2) Recommended Dosage for Administration in Parenteral Nutrition Individualize the dosage based upon the patient's clinical condition, nutritional requirements, and the contribution of oral or enteral phosphorus and potassium intake. (2.4) See full prescribing information for recommendations for daily and maximum dosage.

(2.4)

2.1Preparation and Administration in Intravenous Fluids to Correct Hypophosphatemia 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 pediatric patients less than 12 years of age, use the smallest recommended volume, considering daily fluid requirements and the maximum concentration for peripheral and central administration shown in Table 1. The concentration of the diluted solution should take into consideration the age of the patient, the amounts of phosphorus and potassium in the dose, and is dependent upon whether administration will be through a peripheral or central venous catheter. The recommended maximum concentrations are shown in Table 1: 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) Visually inspect the solution for particulate matter and discoloration before and after dilution and prior to administration. Do not administer unless solution is clear, and seal on the vial is intact.

Administration Check serum potassium and calcium concentrations prior to administration. Normalize the calcium before administering Potassium Phosphates Injection [see Contraindications (4), Warnings and Precautions (5.3, 5.4)] . Potassium phosphates 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 rate of administration may be dependent on the patient and the specific institution policy [see Dosage and Administration (2.2)] .

Storage and Stability Single-Dose Vial (5 mL and 15 mL) For single use only. Discard used vial, including any unused contents. After dilution, the solution is stable for a maximum of 4 hours at room temperature 20°C to 25°C (68°F to 77°F) or 14 days under refrigerati… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 90 words ▾

3 DOSAGE FORMS AND STRENGTHS Potassium phosphates injection, USP is a clear and colorless solution supplied as: phosphorus 15 mmol/5 mL (3 mmol/mL) and potassium 22 mEq/5 mL (4.4 mEq /mL) in a single- dose vial. phosphorus 45 mmol/15 mL (3 mmol/mL) and potassium 66 mEq/15 mL (4.4 mEq/mL) in a single-dose vial. Injection: phosphorus 15 mmol/5 mL (3 mmol/mL) and potassium 22 mEq/5 mL (4.4 mEq/mL) in a single-dose vial. (3) phosphorus 45 mmol/15 mL (3 mmol/mL) and potassium 66 mEq/15 mL (4.4 mEq/mL) in a single-dose vial.

(3)

⛔ Contraindications 76 words ▾

4 CONTRAINDICATIONS Potassium phosphates injection is contraindicated in patients with: hyperkalemia [see Warning and Precautions (5.3)] 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 ) or end stage renal disease [see Warning and Precautions (5.3)] hyperkalemia (4) hyperphosphatemia (4) hypercalcemia or significant hypocalcemia (4) severe renal impairment (eGFR less than 30 mL/min/1.73m 2 ) or end stage renal disease (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Serious Cardiac Adverse Reactions with Undiluted, Bolus, or Rapid Intravenous Administration : Administer only after dilution or admixing; do not exceed the recommended infusion rate. Continuous electrocardiographic (ECG) monitoring may be needed during infusion. (2.2, 5.1) Pulmonary Embolism due to Pulmonary Vascular Precipitates : If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.

(5.2) 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. (5.3, 7.1) Hyperphosphatemia and Hypocalcemia: Monitor serum phosphorus and calcium concentrations during and following infusion. (5.4) Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm infants.

(5.5, 8.4). Hypomagnesemia : Reported in patients with hypercalcemia and diabetic ketoacidosis. Monitor serum magnesium concentrations during treatment.

(5.6) Vein Damage and Thrombosis : Infuse concentrated or hypertonic solutions through a central catheter. (2.1, 2.3, 5.7)

5.1Serious Cardiac Adverse Reactions with Undiluted, 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) 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 "IV 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)] .

5.2Pulmonary 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 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.

5.3Hyperkalemia 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 increas… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Aluminum Toxicity [see Warnings and Precautions (5.5)] Hypomagnesemia [see Warnings and Precautions (5.6)] Vein Damage and Thrombosis [see Warnings and Precautions (5.7)] The following adverse reactions in Table 5 have been reported in clinical studies or postmarketing 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 Postmarketing 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 Adverse reactions include hyperkalemia, hyperphosphatemia, hypocalcemia, and hypomagnesemia.

(6) To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 124 words ▾

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. (5.3, 7.1)

7.1Other Products that Increase Serum Potassium 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)] .

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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.

8.2Lactation 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.

8.4Pediatric Use Safety and effectiveness of potassium phosphates injection have been established in pediatric patients as a source of phosphorus: in intravenous fluids to correct hypophosphatemia when oral or enteral replacement is not possible, insufficient, or contraindicated. for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. 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 (5.6)] .

8.5Geriatric Use 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)] .

8.6Renal Impairment 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 m 2 ) or end stage renal disease [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 (2.2, 2.4)].

🤰 Pregnancy 131 words ▾

8.1Pregnancy 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.

🧒 Pediatric Use 82 words ▾

8.4Pediatric Use Safety and effectiveness of potassium phosphates injection have been established in pediatric patients as a source of phosphorus: in intravenous fluids to correct hypophosphatemia when oral or enteral replacement is not possible, insufficient, or contraindicated. for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. 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 (5.6)] .

🧓 Geriatric Use 64 words ▾

8.5Geriatric Use 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)] .

🆘 Overdosage 171 words ▾

10 OVERDOSAGE Hyperphosphatemia Administration of excessive doses of intravenous potassium phosphates in intravenous fluids 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 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 112 words ▾

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.

12.3Pharmacokinetics 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 49 words ▾

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 109 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Potassium phosphates injection, USP is a clear and colorless solution supplied as phosphorus 3 mmol/mL and potassium 4.4 mEq/mL as shown: Unit of Sale Strength Each NDC 70069- 746 -25 Carton containing 25 units Phosphorus 15 mmol/5 mL and Potassium 22 mEq/5 mL NDC 70069- 746- 01 5 mL single dose, plastic vial NDC 70069- 747 -25 Carton containing 25 units Phosphorus 45 mmol/15 mL and Potassium 66 mEq/15 mL NDC 70069- 747 -01 15 mL single dose, plastic 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.

📋 Description 179 words ▾

11 DESCRIPTION Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials.

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. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate.

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.

💬 Information for Patients 83 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers or home healthcare providers of the following risks of potassium phosphates injection: Serious cardiac adverse reactions with undiluted, bolus or rapid intravenous administration [see Warnings and Precautions (5.1)] Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.2)] Hyperkalemia [see Warnings and Precautions (5.3)] Hyperphosphatemia and hypocalcemia [see Warnings and Precautions (5.4)] Aluminum toxicity [see Warnings and Precautions (5.5)] Hypomagnesemia [see Warnings and Precautions (5.6)] Vein damage and thrombosis [see Warnings and Precautions (5.7)]

🧬 Pharmacokinetics 60 words ▾

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.

📄 Package Label / Principal Display Panel 24 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label (5 mL) Carton Label (5 mL) Container Label (15 mL) Carton Label (15 mL) Image Image Image Image

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.5K
Units reimbursed last 4 qtrs
88.9K
Gross reimbursed last 4 qtrs
$517.2K
Avg / prescription
$208.63
Avg / unit
$5.8190
Latest quarter Q1 2026
994Rx
Fee-for-service vs managed care ⓘ
98% FFS
Fee-for-service · 2,425 Rx Managed care · 54 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 795 units · 70.2 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 210 units · 3.6 per 100k residents WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,345 units · 10.7 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 12,402 units · 31.8 per 100k residents CA Utah: no data reported UT Colorado: 36,214 units · 616 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 185 units · 4.1 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 37,110 units · 727 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 618 units · 2.7 per 100k residents FL
Units reimbursed · per 100k residents
2.7727
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Alabama 727 /100k
2 Colorado 616 /100k
3 Montana 70.2 /100k
4 California 31.8 /100k
5 Illinois 10.7 /100k
6 Kentucky 4.1 /100k
7 Wisconsin 3.6 /100k
8 Florida 2.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Potassium Phosphate — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Potassium Phosphate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$13.5K
Claims incl. refills
70
Beneficiaries
14
Spend / beneficiary
$965.45
Spend / claim
$193.09
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Somerset Therapeutics, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Somerset Therapeutics, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 70069-0746-25 · Somerset 70069-0752-25 · Somerset →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.