Sodium Phosphates
Sodium Phosphate, Monobasic, Monohydrate
Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-170Sodium Phosphates also known as Sodium Phosphate, Monobasic, Monohydrate is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Sodium Phosphates is 63323-170. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Sodium Phosphates drug includes Sodium Phosphate, Dibasic, Anhydrous - 142 mg/mL Sodium Phosphate, Monobasic, Monohydrate - 276 mg/mL . The currest status of Sodium Phosphates drug is Active.
Drug Information:
| Drug NDC: | 63323-170 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Sodium Phosphates |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sodium Phosphate, Monobasic, Monohydrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Fresenius Kabi Usa, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS - 142 mg/mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - 276 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 06 Sep, 2000 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Fresenius Kabi USA, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1872384
1872443
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0363323170158
0363323170059
|
| UPC stands for Universal Product Code. |
| UNII: | 22ADO53M6F
593YOG76RN
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63323-170-05 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-170-05) / 5 mL in 1 VIAL, SINGLE-DOSE | 06 Sep, 2000 | N/A | No |
| 63323-170-15 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-170-15) / 15 mL in 1 VIAL, SINGLE-DOSE | 06 Sep, 2000 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Sodium phosphates sodium phosphate, monobasic, monohydrate phosphoric acid sodium hydroxide sodium phosphate, monobasic, monohydrate phosphate ion sodium phosphate, dibasic, anhydrous phosphate ion
Indications and Usage:
Indications and usage sodium phosphates injection, usp is indicated as a source of phosphate, 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 (4 meq/ml) must be calculated into total electrolyte dose of such prepared solutions.
Warnings:
Warnings 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. sodium phosphates injection must be diluted and thoroughly mixed before use. to avoid phosphate intoxication, infuse solutions containing sodium phosphate slowly. infusing high concentrations of phosphate may result in a reduction of serum calcium and symptoms of hypocalcemic tetany. calcium levels should be monitored. solutions con
Read more...taining sodium ion 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.
Dosage and Administration:
Dosage and administration sodium phosphates injection 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, inorganic 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 of phosphate and milliequivalents of sodium. in patients on tpn, approximately 10 to 15 mmol of phosphorus (equivalent to 310 to 465 mg elemental phosphorus) per liter bottle of tpn solution is usually adequate to maintain normal serum phosphate, though larger amounts may be required in hypermetabolic states. the amount of sodium which accompanies the addition of phosphate also should be kept in mind, and if necessary, serum sodium levels should be monitored. the suggested dose of phosphorus for
Read more... infants receiving tpn is 1.5 to 2 mmol/kg/day. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications:
Contraindications sodium phosphate is contraindicated in diseases where high phosphate or low calcium levels may be encountered, and in patients with hypernatremia.
Adverse Reactions:
Adverse reactions adverse reactions involve the possibility of phosphate intoxication. phosphate intoxication results in a reduction of serum calcium and the symptoms are those of hypocalcemic tetany (see warnings ).
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 )
Description:
Description sodium phosphates injection, usp, 3 mmol/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: monobasic sodium phosphate, monohydrate, 276 mg; dibasic sodium phosphate, anhydrous, 142 mg (equivalent to dibasic sodium phosphate, heptahydrate, 268 mg); water for injection q.s. in the 5 ml and 15 ml product, phosphoric acid and/or naoh may have been added for ph adjustment. each ml provides 3 mmol of phosphorus and 4 meq sodium. it contains no bacteriostat, antimicrobial agent or added buffer. the ph is 5.7 (approx.). the osmolar concentration is 7 mosmol/ml (calc.) the solution is intended as an alternative to potassium phosphate to provide phosphate ion (po 4 3- ) for addition to large volume infusion fluids for intravenous use. sodium phosphates, usp, monohydrate monobasic is chemically designated nah 2 po 4 ⢠h 2 o. occurs as white, odorless crystals or granules freely soluble in water. dibasic sodium phosphate, usp, anhydrous, is chemically designated na 2 hpo 4 . occurs as a colorless or white granular salt freely soluble in water.
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. phosphate 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. phosphate, present in large am
Read more...ounts 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 (tpn), or other lengthy periods of intravenous infusions. it has been suggested that patients receiving tpn receive 20 meq phosphate (13 mmol phosphate)/1000 kcal from dextrose. serum phosphate levels should be regularly monitored and appropriate amounts of phosphate should be added to the infusions to maintain normal serum phosphate levels. intravenous infusion of inorganic phosphate may be accompanied by a decrease in the serum level and urinary excretion of calcium. the normal level of serum inorganic phosphate is 3 to 4.5 mg/100 ml in adults; 4 to 7 mg/100 ml in children. intravenously infused phosphate not taken up by the tissues is excreted almost entirely in the urine. plasma phosphate is believed to be filterable by the renal glomeruli, and the major portion of filtered phosphate (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/l. 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 ââsodium cation pumpââ). 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:
How supplied product no. ndc no. volume 17005px 63323-170-05 5 ml in a 10 ml vial 17015px 63323-170-15 15 ml in a 30 ml vial 11850 63323-118-50 50 ml in a 50 ml vial these vials are flip-top, single dose vials, packaged 25 vials per tray. the vials marked with ââpxââ are partially filled to facilitate transfer of the contents. do not administer unless solution is clear and seal intact. discard unused portion. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature].
Package Label Principal Display Panel:
Package label â principal display panel â sodium phosphates 5 ml single dose vial label ndc 63323-170-05 17005px sodium phosphates injection, usp phosphorus 15 mmol / 5 ml (3 mmol/ml) sodium 20 meq / 5ml (4 meq/ml) must be diluted prior to iv use 5 ml single dose vial package label â principal display panel â sodium phosphates 5 ml single dose vial label
Package label â principal display panel â sodium phosphates 5 ml single dose vial tray label ndc 63323-170-05 17005px sodium phosphates injection, usp phosphorus 15 mmol / 5 ml (3 mmol/ml) sodium 20 meq / 5ml (4 meq/ml) must be diluted prior to iv use 25 x 5 ml single dose vials package label â principal display panel â sodium phosphates 5 ml single dose vial tray label
Package label â principal display panel â sodium phosphates 15 ml single dose vial label ndc 63323-170-15 17015px sodium phosphates injection, usp phosphorus 45 mmol / 15 ml (3 mmol/ml) sodium 60 meq / 15ml (4 meq/ml) must be diluted prior to iv use 15 ml rx only single dose vial package label â principal display panel â sodium phosphates 15 ml single dose vial label
Package label â principal display panel â sodium phosphates 15 ml single dose vial tray label ndc 63323-170-15 17015px sodium phosphates injection, usp phosphorus 45 mmol / 15 ml (3 mmol/ml) sodium 60 meq / 15ml (4 meq/ml) must be diluted prior to iv use 25 x 15 ml rx only single dose vials package label â principal display panel â sodium phosphates 15 ml single dose vial tray label