DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride 2.5 g/100mL; 538 mg/100mL; 448 mg/100mL; 18.4 mg/100mL; 5.08 mg/100mL Solution
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
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🧪 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.
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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 | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| 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 |
|---|---|---|---|---|---|---|
| Delflex 2.5 g/100mL; 538 mg/100mL; 448 mg/100mL; 18.4 mg/100mL; 5.08 mg/100mLthis 49230-0209-52 | Fresenius | 5000 ml | — | AT | FDA listed | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 49230-0209-23 | 6 BAG in 1 CARTON (49230-209-23) / 2000 mL in 1 BAG | 1992-08-19 | Active |
| 49230-0209-30 | 4 BAG in 1 CARTON (49230-209-30) / 3000 mL in 1 BAG | 1992-08-19 | Active |
| 49230-0209-32 | 4 BAG in 1 CARTON (49230-209-32) / 3000 mL in 1 BAG | 1992-08-19 | Active |
| 49230-0209-50 | 2 BAG in 1 CARTON (49230-209-50) / 5000 mL in 1 BAG | 1992-08-19 | Active |
| 49230-0209-60 | 2 BAG in 1 CARTON (49230-209-60) / 6000 mL in 1 BAG | 1992-08-19 | Active |
| 49230-0209-62 | 2 BAG in 1 CARTON (49230-209-62) / 6000 mL in 1 BAG | 1992-08-19 | Active |
| 49230-0209-92 | 5 BAG in 1 CARTON (49230-209-92) / 2000 mL in 1 BAG | 1992-08-19 | Active |
| 49230-0209-94 | 5 BAG in 1 CARTON (49230-209-94) / 2500 mL in 1 BAG | 1992-08-19 | Active |
| 49230-0209-95 | 4 BAG in 1 CARTON (49230-209-95) / 3000 mL in 1 BAG | 1992-08-19 | Active |
| 49230-0209-52 You're viewing this | 2 BAG in 1 CARTON (49230-209-52) / 5000 mL in 1 BAG | 1992-08-19 | Active |
Pack size FAQ
What quantity is in NDC 49230-0209-52?
What NDC number is used to bill for this package of DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride 2.5 g/100mL; 538 mg/100mL; 448 mg/100mL; 18.4 mg/100mL; 5.08 mg/100mL Solution?
🧭 About this NDC listing & data coverage
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 | — Not published for this NDC No photo available yet for this listing. |
| 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) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
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Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1. INDICATIONS AND USAGE DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis. For treatment of chronic kidney failure. ( 1 )
⏱️ Dosage and Administration ▾
2. DOSAGE AND ADMINISTRATION For intraperitoneal dialysis only. ( 2 )
2.1Basic Dosing Information DELFLEX® is intended for intraperitoneal administration only. Not for intravenous or intra-arterial administration. The mode of therapy, frequency of treatment, formulation, exchange volume, duration of dwell, and length of dialysis should be selected by the physician responsible for the treatment of the individual patient.
Utilize the peritoneal dialysis solution with lowest level of osmolarity consistent with the fluid removal requirements for that exchange. Do not store solutions containing additives.
2.2Administration Instructions Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not heat in a microwave oven. Get Ready Clean work surface and gather supplies: Masks (enough for everyone in the room).
Warmed DELFLEX peritoneal dialysis solution bag with attached stay•safe exchange set. stay•safe organizer, a stand-alone item provided separately. Povidone iodine prefilled stay•safe cap, a stand-alone item provided separately. IV Pole (optional).
Prescribed medication(s), if ordered by your healthcare provider. After removing the overwrap, check your DELFLEX solution bag(s) for strength, clarity, amount, leaks, and expiration date. Do not use DELFLEX solution if leaks are found, the solution bag is damaged, the solution is cloudy or discolored, and/or the product is expired.
Color may vary from clear to slightly yellow but does not affect efficacy and may be used. Prepare supplies: Retrieve stay•safe catheter extension set and ensure clamp is closed. Tear the overwrap from the slit edge down the length of the inner bag to open.
Wipe away any moisture from the solution bags. Some opacity may be observed in the plastic of the bag and/ or tubing and is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety.
The opacity will diminish gradually. Visually check that the solution bag tubing is free from kinks. If kinks are present, straighten tubing to allow the solution to flow freely.
Note: Retain DELFLEX peritoneal dialysis bag sample for manufacturer evaluation and notify your healthcare provider if any of the above defects are found. Put on mask. Wash your hands per facility protocol.
Position the stay•safe organizer at the edge of your clean work surface or with the stay•safe holder on the IV pole. Remove color-coded cover: Turn the blue dial as directed by the arrow in the color—coded cover. Remove the colored—coded cover from the stay•safe DISC.
The blue dial will be in Position 1 ( ) DRAIN. Prepare organizer and solution bag: Place the stay•safe DISC and tubing into the organizer and tubing channels on the organizer. If you will be adding medication(s): Clean hands (as per facility's protocol).
Clean the medication port as instructed by your healthcare provider. Add the medicine(s). Turn the bag upside down several times to mix the medicine(s).
Hang the DELFLEX peritoneal dialysis solution bag on the IV pole and place the drain bag with the clear side up on the floor. Break cone of the administration port. Remove new stay•safe cap from its package and place stay•safe cap into the left notch of the organizer.
Place stay•safe catheter extension set into organizer. Clean hands (as per facility's protocol). Place stay•safe catheter extension set into the right notch of the organizer.
Ensure clamp of stay•safe catheter extension set is closed. Remove protective cap from stay•safe DISC and set aside. Connect stay•safe catheter extension set to the stay•safe DISC.
Unscrew stay•safe catheter extension set from its cap. Immediately connect the stay•safe catheter extension set to the stay•safe DISC. Open the white clamp of stay•safe catheter extension set and start DRAIN.
Place discarded protective cap from stay•safe DISC onto the used stay•safe cap in the…
💊 Dosage Forms and Strengths ▾
3. DOSAGE FORMS AND STRENGTHS DELFLEX peritoneal dialysis solutions are delivered in transparent single-dose flexible bags. The solution is clear with color being slightly yellow to colorless.
All DELFLEX peritoneal dialysis solutions have overfills declared on the bag label. The flexible bag has the capacity for drainage in excess of their stated fill volume for ultrafiltration from the patient. DELFLEX peritoneal dialysis solutions with an attached stay•safe exchange set are available in the sizes and formulations shown in Table 1 .
Table 1. DELFLEX peritoneal dialysis solution with attached stay•safe exchange set sizes and formulations 2L 2.5L 3L DELFLEX Low Magnesium, Low Calcium with 1.5% Dextrose X X X DELFLEX Low Magnesium, Low Calcium with 2.5% Dextrose X X X DELFLEX Low Magnesium, Low Calcium with 4.25% Dextrose X X X DELFLEX solutions are available in multiple compositions, calculated osmolarity, pH, and ionic concentrations. See full prescribing information for detailed descriptions of each formulation.
( 3 , 11 )
⛔ Contraindications ▾
4. CONTRAINDICATIONS None. None
⚠️ Warnings and Cautions ▾
5. WARNINGS AND PRECAUTIONS Monitor patient for electrolyte, fluid, and nutrition imbalances. ( 5.1 ) Encapsulating Peritoneal Sclerosis (EPS) ( 5.2 ) Peritonitis: Initiate appropriate antimicrobial therapy ( 5.2 ) Monitor for Lactic Acidosis in patients at risk. ( 5.3 )
5.1Electrolyte, Fluid and Nutrition Imbalances Peritoneal dialysis may affect a patient's protein, water-soluble vitamin, potassium, sodium, chloride, bicarbonate, and magnesium levels and volume status. Monitor electrolytes and blood chemistry periodically and take appropriate clinical action. Potassium is omitted from DELFLEX solutions because dialysis may be performed to correct hyperkalemia.
In situations where there is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia. To avoid the risk of severe dehydration or hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with lowest level of osmolarity consistent with the fluid removal requirements for that exchange. Significant loss of protein, amino acids and water-soluble vitamins may occur during peritoneal dialysis.
Replacement therapy should be provided as necessary.
5.2Peritonitis and Encapsulating Peritoneal Sclerosis Infectious and aseptic peritonitis has been associated with peritoneal dialysis therapy. Following DELFLEX use, inspect the drained fluid for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis. Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/or peritonitis.
If peritonitis occurs, treat with appropriate therapy. Encapsulating peritoneal sclerosis (EPS), sometimes fatal, is a complication of peritoneal dialysis therapy.
5.3Lactic Acidosis Monitor patients with conditions known to increase the risk of lactic acidosis [e.g., severe hypotension or sepsis that can be associated with acute kidney failure, inborn errors of metabolism, treatment with drugs such as nucleoside/ nucleotide reverse transcriptase inhibitors (NRTIs)] for lactic acidosis before the start of treatment and during treatment with DELFLEX. Solutions containing the lactate ion should be used with great care in patients with metabolic or respiratory alkalosis. Lactate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency.
5.4Over Infusion Over infusion of peritoneal dialysis solution volume into the peritoneal cavity may be characterized by abdominal distention, feeling of fullness and/or shortness of breath. Drain the peritoneal dialysis solution from the peritoneal cavity to treat over infusion.
🤒 Adverse Reactions ▾
6. ADVERSE REACTIONS Solution related adverse reactions may include peritonitis, catheter site infection, electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypertension, hypotension, disequilibrium syndrome, muscle cramping, abdominal pain, abdominal distension, and abdominal discomfort. Adverse reactions may include peritonitis, catheter site infection, electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypertension, disequilibrium syndrome, muscle cramping, abdominal pain, abdominal distension, and abdominal discomfort.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care North America at 1-800-323-5188 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
👥 Use in Specific Populations ▾
8. USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary DELFLEX solutions consist of electrolytes, lactate, and bicarbonate at physiological levels, and glucose to facilitate ultrafiltration. While there are no adequate and well controlled studies in pregnant women, appropriate administration of DELFLEX with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm. Animal reproduction studies have not been conducted with DELFLEX.
The estimated background risk of major birth defects and miscarriage for the indicated population are 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.
8.2Lactation Risk Summary The components of DELFLEX solutions are excreted in human milk. Appropriate administration of DELFEX solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to harm a nursing infant.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary DELFLEX solutions consist of electrolytes, lactate, and bicarbonate at physiological levels, and glucose to facilitate ultrafiltration. While there are no adequate and well controlled studies in pregnant women, appropriate administration of DELFLEX with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm. Animal reproduction studies have not been conducted with DELFLEX.
The estimated background risk of major birth defects and miscarriage for the indicated population are 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.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧬 Clinical Pharmacology ▾
12. CLINICAL PHARMACOLOGY
12.1Mechanism of Action DELFLEX peritoneal dialysis solutions are hypertonic peritoneal dialysis solutions containing dextrose, a monosaccharide, as the primary osmotic agent. An osmotic gradient must be created between the peritoneal membrane and the dialysis solution in order for ultrafiltration to occur. The hypertonic concentration of glucose in DELFLEX solutions exert an osmotic pressure across the peritoneal membrane resulting in transcapillary ultrafiltration.
Like other peritoneal dialysis solutions, DELFLEX solutions contain electrolytes to facilitate the correction of acidbase and electrolyte abnormalities. DELFLEX solutions contain a buffer, lactate, to help normalize acid-base abnormalities.
12.3Pharmacokinetics Absorption Glucose can be rapidly absorbed from the peritoneal cavity by diffusion and appears quickly in the circulation due to the high glucose concentration gradient between DELFLEX solutions compared to blood capillary glucose level. Absorption per unit time will be the highest at the start of an exchange and decreases over time. The rate of glucose absorption will be dependent upon the transport characteristics of the patient's peritoneal membrane as determined by a peritoneal equilibration test (PET).
Glucose absorption will also depend upon the concentration of glucose used for the exchange and the length of the dwell. Transport of other molecules will be dependent upon the molecular size of the solute, the concentration gradient, and the effective peritoneal surface area as determined by the PET. Metabolism and Elimination Glucose is metabolized by normal cellular pathways (i.e., glycolysis).
Metabolism of lactate occurs in the liver and results in the generation of the bicarbonate. Glucose not absorbed during PD exchange procedure is removed by drainage of the PD solution from the peritoneal cavity. Drug Interaction Studies Antibiotics No formal clinical drug interaction studies have been performed.
In vitro studies of the following medications have demonstrated stability with DELFLEX solutions: cefazolin, ceftazidime, gentamicin, and vancomycin.
🧬 Mechanism of Action ▾
12.1Mechanism of Action DELFLEX peritoneal dialysis solutions are hypertonic peritoneal dialysis solutions containing dextrose, a monosaccharide, as the primary osmotic agent. An osmotic gradient must be created between the peritoneal membrane and the dialysis solution in order for ultrafiltration to occur. The hypertonic concentration of glucose in DELFLEX solutions exert an osmotic pressure across the peritoneal membrane resulting in transcapillary ultrafiltration.
Like other peritoneal dialysis solutions, DELFLEX solutions contain electrolytes to facilitate the correction of acidbase and electrolyte abnormalities. DELFLEX solutions contain a buffer, lactate, to help normalize acid-base abnormalities.
📦 How Supplied / Storage and Handling ▾
16. HOW SUPPLIED/STORAGE AND HANDLING DELFLEX peritoneal dialysis solutions with attached stay•safe exchange set are available in the sizes and formulations shown in Table 1 [ Dosage Forms and Strengths ].( 3 ) DELFLEX peritoneal dialysis solutions are delivered in transparent, single-dose flexible bags. The solution is clear with color being slightly yellow to colorless.
Table 3. DELFLEX peritoneal dialysis with attached stay•safe exchange set NDC designations Magnesium (Mg); Calcium (Ca) Unit Volume 2L 2.5L 3L Number of units per carton 5 5 4 Low Mg/Low Ca 1.5% Dextrose 49230-206-92 49230-206-94 49230-206-95 Low Mg/Low Ca 2.5% Dextrose 49230-209-92 49230-209-94 49230-209-95 Low Mg/Low Ca 4.25% Dextrose 49230-212-92 49230-212-94 49230-212-95 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F). See USP Controlled Room Temperature.
Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Keep DELFLEX and all medicines out of the reach of children.
📋 Description ▾
11. DESCRIPTION The DELFLEX® peritoneal dialysis solutions (low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers.
The stay•safe exchange set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 2 . Table 2.
Composition, calculated osmolarity, pH and ionic concentration Composition/100mL Total Osmolarity (mOsmoL/L) (calc) pH (5.0 - 6.0) Ionic Concentration (mEq/L) Dextrose Hydrous, USP (C 6 H 12 O 6 •H 2 O) Sodium Chloride, USP (NaCl) Sodium Lactate (C 3 H 5 NaO 3 ) Calcium Chloride, USP (CaCl 2 •2H 2 O) Magnesium Chloride, USP (MgCl 2 •6H 2 O) Sodium Calcium Magnesium Chloride Lactate DELFLEX Low Magnesium, Low Calcium with 1.5% Dextrose 1,500 mg 538 mg 448 mg 18.4 mg 5.08 mg 344 5.5 132 2.5 0.5 95 40 DELFLEX Low Magnesium, Low Calcium with 2.5% Dextrose 2,500 mg 538 mg 448 mg 18.4 mg 5.08 mg 394 5.5 132 2.5 0.5 95 40 DELFLEX Low Magnesium, Low Calcium with 4.25% Dextrose 4,250 mg 538 mg 448 mg 18.4 mg 5.08 mg 483 5.5 132 2.5 0.5 95 40 Dextrose, USP, is chemically designated D-glucose monohydrate (C6H12O6•H2O) a hexose sugar freely soluble in water.
The structural formula is shown here: Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl 2 •2H 2 O) white fragments or granules freely soluble in water. Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl 2 •6H 2 O) colorless flakes or crystals very soluble in water. Sodium lactate solution, USP, is chemically designated (CH 3 CH(OH) COONa), a 60% aqueous solution miscible in water.
Sodium chloride, USP, is chemically designated (NaCI), a white, crystalline compound freely soluble in water. Water for injection, USP, is chemically designated (H 2 O). Hydrochloric Acid or Sodium Hydroxide may be added for pH adjustment. pH is 5.5 ± 0.5.
Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
Since the inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the overwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers. Figure
💬 Information for Patients ▾
17. PATIENT COUNSELING INFORMATION Aseptic technique must be used throughout the procedure and at its termination in order to reduce the possibility of infection. The solution bag should remain in the carton and the overwrap intact until time of use.
Use only after checking for strength, clarity, amount, leaks, and expiration date. Advise patients that DELFLEX peritoneal dialysis solution should not be heated in a microwave oven. Disconnect from stay•safe DISC only when the blue dial is in position 4( ) to ensure the fluid path of the stay•safe catheter extension set is sealed.
Care should be taken to ensure that there is not any leakage around the catheter, since if not controlled, the leakage can create edema from subcutaneous infiltration of the dialysis solution. The leakage willl also create an inaccurate fluid balance measurement. If any leakage is identified, do not proceed with infusion and notify your physician.
Fresenius Medical Care North America 920 Winter Street Waltham, MA 02451 1-800-323-5188 © 2020 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, triangle logo, DELFLEX, stay•safe are trademarks of Fresenius Medical Care Holding, Inc. or its affiliated companies.
Figure Figure