Sodium Phosphates sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous 276 mg/mL; 142 mg/mL Injection, Solution
🆔 Identity & classification
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🧪 Inactive Ingredients / Excipients
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UNII 059QF0KO0R
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1 inactive ingredient listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $23.60 | $8,848.43 / 375 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sodium Phosphates 276 mg/mL; 142 mg/mL 00409-7391-72 | Hospira, | 25 vials | — | AP | FDA listed | — |
| Sodium Phosphates 276 mg/mL; 142 mg/mLthis 00517-7315-25 | American | 25 vials | — | AP | FDA listed | — |
| Sodium Phosphates 276 mg/mL; 142 mg/mL 63323-0170-05 | Fresenius | 25 vials | — | — | FDA listed | — |
| Sodium Phosphates 276 mg/mL; 142 mg/mL 63323-0881-16 | Fresenius | 25 vials | — | AP | FDA listed | — |
| Sodium Phosphates 276 mg/mL; 268 mg/mL 65145-0201-25 | Caplin | 25 vials | — | AP | FDA listed | — |
| Sodium Phosphates 276 mg/mL; 268 mg/mL 68462-0729-25 | GLENMARK | 25 vials | — | AP | FDA listed | — |
| Sodium Phosphates 276 mg/mL; 142 mg/mL 00517-7350-25 | American | 25 vials | — | AP | FDA listed | — |
| Sodium Phosphates 276 mg/mL; 142 mg/mL 72572-0309-25 | Civica, | 25 vials | — | AP | FDA listed | — |
| Sodium Phosphates 276 mg/mL; 142 mg/mL 00517-7305-25 | American | 25 vials | — | AP | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00517-7315-25 You're viewing this | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-7315-25) / 15 mL in 1 VIAL, SINGLE-DOSE (0517-7315-01) | 2024-06-21 | Active |
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| 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 |
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| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Sodium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na + 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Sodium Phosphates Injection, USP, 3 mM P/mL is administered intravenously only after dilution and thorough mixing in a larger volume of fluid . The dose and rate of administration are dependent upon the individual needs of the patient. Serum sodium, phosphorus and calcium levels should be monitored as a guide to dosage.
Using aseptic technique, all or part of the contents of one or more vials may be added to other intravenous fluids to provide any desired number of millimoles (mM) of phosphorus. In patients on total parenteral nutrition, approximately 12 to 15 mM of phosphorus (equivalent to 372 to 465 mg elemental phosphorus) per liter bottle of TPN solution containing 250 g dextrose is usually adequate to maintain normal serum phosphorus, though larger amounts may be required in hypermetabolic states. The amount of sodium and phosphorus which accompanies the addition of sodium phosphate also should be kept in mind, and if necessary, serum sodium levels should be monitored.
The suggested dose of phosphorus for infants receiving TPN is 1.5 to 2 mM P/kg/day. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.
⛔ Contraindications ▾
CONTRAINDICATIONS Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia.
⚠️ Warnings ▾
WARNINGS Sodium Phosphates Injection, USP, 3 mM P/mL must be diluted and thoroughly mixed before use. To avoid phosphorus intoxication, infuse solutions containing sodium phosphate slowly. Infusing high concentrations of phosphorus may result in a reduction of serum calcium and symptoms of hypocalcemic tetany.
Calcium levels should be monitored. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse reactions involve the possibility of phosphorus intoxication. Phosphorus intoxication results in a reduction of serum calcium and the symptoms are those of hypocalcemic tetany. See WARNINGS . To report SUSPECTED ADVERSE REACTIONS, contact American Regent, Inc. at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🆘 Overdosage ▾
OVERDOSAGE In the event of overdosage, discontinue infusions containing sodium phosphate immediately and institute corrective therapy to restore depressed serum calcium and to reduce elevated serum sodium levels. See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS .
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Phosphorus in the form of organic and inorganic phosphate has a variety of important biochemical functions in the body and is involved in many significant metabolic and enzyme reactions in almost all organs and tissues. It exerts a modifying influence on the steady state of calcium levels, a buffering effect on acid-base equilibrium and a primary role in the renal excretion of hydrogen ion. Phosphorus is present in plasma and other extracellular fluid, in cell membranes and intracellular fluid, as well as in collagen and bone tissues.
Phosphorus in the extracellular fluid is primarily in inorganic form and plasma levels may vary somewhat with age. The ratio of disodium phosphate and monosodium phosphate in the extracellular fluid is 4 to 1 (80% to 20%) at the normal pH of 7.4. This buffer ratio varies with the pH, but owing to its relatively low concentration, it contributes little to the buffering capacity of the extracellular fluid.
Phosphorus, present in large amounts in erythrocytes and other tissue cells, plays a significant intracellular role in the synthesis of high energy organic phosphates. It has been shown to be essential to maintain red cell glucose utilization, lactate production, and the concentration of both erythrocyte adenosine triphosphate (ATP) and 2,3 diphosphoglycerate (DPG), and must be deemed as important to other tissue cells. Hypophosphatemia should be avoided during periods of total parenteral nutrition, or other lengthy periods of intravenous infusions.
It has been suggested that patients receiving total parenteral nutrition receive 12 to 15 mM phosphorus per 250 g of dextrose. Serum phosphorus levels should be regularly monitored and appropriate amounts of phosphorus should be added to the infusions to maintain normal serum phosphorus levels. Intravenous infusion of inorganic phosphorus may be accompanied by a decrease in the serum level and urinary excretion of calcium.
The normal level of serum phosphorus is 3.0 to 4.5 mg/100 mL in adults; 4.0 to 7.0 mg/100 mL in children. Intravenously infused phosphorus not taken up by the tissues is excreted almost entirely in the urine. Plasma 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.
Many modifying influences tend to alter the amount excreted in the urine. Sodium is the principal cation of extracellular fluid. It comprises more than 90% of the total cations at its normal plasma concentration of approximately 142 mEq/liter.
While the sodium ion can diffuse across cell membranes, intracellular sodium is maintained at a much lower concentration than extracellular sodium through the expenditure of energy by the cell (so called "sodium cation pump"). Loss of intracellular potassium ion is usually accompanied by an increase in intracellular sodium ion. When serum sodium concentration is low, the secretion of antidiuretic hormone (ADH) by the pituitary is inhibited, thereby preventing water reabsorption by the distal renal tubules.
On the other hand, adrenal secretion of aldosterone increases renal tubular reabsorption of sodium in an effort to re-establish normal serum sodium concentration.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Sodium Phosphates Injection, USP, 3mM P/mL is supplied as a clear, colorless solution as per below. Unit of Sale Concentration Unit of Use NDC 0517-7305-25 Tray containing 25 vials 15 mM P/5 mL (3 mM P/mL) containing 20 mEq Na + /5 mL (4 mEq/mL) NDC 0517-7305-01 5 mL Single-Dose Plastic Vial NDC 0517-7315-25 Tray containing 25 vials 45 mM P/15 mL (3 mM P/mL) containing 60 mEq Na + /15 mL (4 mEq/mL) NDC 0517-7315-01 15 mL Single-Dose Plastic Vial NDC 0517-7350-25 Tray containing 25 vials 150 mM P/50 mL (3 mM P/mL) containing 200 mEq Na + /50 mL (4 mEq/mL) NDC 0517-7350-01 50 mL Single-Dose Plastic Vial Each container is partially filled to provide air space needed for complete vacuum withdrawal of the contents into the I.V. container.
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] RQ1105-A Rev. 01/2024 ARL Logo
📋 Description ▾
DESCRIPTION Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted.
Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO 4 .
It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc).
The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH 2 PO 4 • H 2 O, white, odorless crystals or granules freely soluble in water.
Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na 2 HPO 4 , colorless or white granular salt freely soluble in water. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene.
The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.