Mannitol 250 mg/mL Injection, Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Osmotic Diuretic class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Mannitol — tap one for details:
Mannitol may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 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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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 | $9.98 | $12,472.88 / 1250 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J2151 | $0.071 / J2151 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Mannitol 12.5 g/50mL 00404-9905-50 | Henry | 1 vial | — | — | FDA listed | — |
| Mannitol 12.5 g/50mL 00409-4031-01 | Hospira, | 25 vials | — | — | FDA listed | — |
| Mannitol 12.5 g/50mL 51662-1468-01 | HF | 50 ml | — | — | FDA listed | — |
| Mannitol 250 mg/mLthis 63323-0024-25 | Fresenius | 25 vials | — | AP | FDA listed | — |
| Mannitol 250 mg/mL 84549-0024-25 | ProPharma | 50 ml | — | 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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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63323-0024-25 You're viewing this | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-024-25) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-024-01) | 2000-03-19 | Active |
🧭 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 | ✓ 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 | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE For Intravenous Injection Mannitol Injection, USP is indicated for the following therapeutic uses: • The promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established. • The reduction of intracranial pressure and treatment of cerebral edema by reducing brain mass. • The reduction of elevated intraocular pressure when it cannot be lowered by other means. • The promotion of urinary excretion of toxic substances.
For Urologic Irrigation Mannitol solution, 2.5% is indicated as an irrigation solution in transurethral prostatic resection or other transurethral surgical procedures.
For Intravenous Injection Mannitol Injection, USP is indicated for the following therapeutic uses: • The promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established. • The reduction of intracranial pressure and treatment of cerebral edema by reducing brain mass. • The reduction of elevated intraocular pressure when it cannot be lowered by other means. • The promotion of urinary excretion of toxic substances.
For Urologic Irrigation Mannitol solution, 2.5% is indicated as an irrigation solution in transurethral prostatic resection or other transurethral surgical procedures.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION For Intravenous Injection General Recommendations –Give mannitol injection only intravenously. The total dosage, concentration and rate of administration should be governed by the nature and severity of the condition being treated, fluid requirement and urinary output. Usual adult dosage ranges from 50 to 200 g in 24 hours but in most instances an adequate response will be achieved at a dosage of approximately 100 g in 24 hours.
The rate is usually adjusted to maintain an adequate urine flow (at least 30 to 50 mL/hr). Test Dose –In marked oliguria or inadequate renal function a test dose of mannitol should be given. The test dose may be approximately 0.2 g/kg (about 50 mL of a 25% solution) infused in three to five minutes to produce an adequate urine flow (at least 30 to 50 mL/hr).
If urine flow does not increase within two or three hours a second test dose may be given. If there is an inadequate response the patient should be reevaluated. Prevention of Acute Renal Failure (Oliguria) –When used during surgery, immediately postoperatively or following trauma, 50 to100 g of mannitol as a 5 to 25% solution maybe given.
The concentration and amount will depend upon the fluid requirements of the patient. Following suspected or actual hemolytic transfusion reactions 20 g of mannitol may be given intravenously over a five minute period to provoke diuresis. If diuresis does not occur the 20 g dose may be repeated.
If there is an adequate urine flow (30 to 50 mL/hr) then intravenous fluids containing not more than 50 to 75 mEq of sodium per liter should be given in sufficient volume to match the desired urine flow (100 mL/hr) until fluids can be taken orally. Treatment of Oliguria –The usual dose for treatment of oliguria is 50 to 100 g as a 15 to 25% solution. Reduction of Intracranial Pressure, Cerebral Edema or Intraocular Pressure –A 25% solution of mannitol is recommended since its effectiveness depends on establishing intravascular hyperosmolarity.
When used before or after surgery, a total dose of 1.5 to 2 g/kg can be given over a period of 30 to 60 minutes. Careful evaluation must be made of the circulatory and renal reserve prior to and during use of mannitol at this relatively high dose and rapid infusion rate. Careful attention must be paid to fluid and electrolyte balance, body weight, and total input and output before and after infusion of mannitol.
Evidence of reduced cerebral spinal fluid pressure may be observed within 15 minutes after starting infusion. Maximal reduction of intraocular pressure occurs 30 to 60 minutes after injection. Urinary Excretion of Toxic Substances –Mannitol in 5 to 25% solutions is used as an infusion as long as indicated if the level of urinary output remains high.
The concentration will depend upon the fluid requirement and urinary output. Intravenous water and electrolytes must be given to replace the loss of these substances in the urine, sweat and expired air. If benefits are not observed after 200 g of mannitol are given, discontinue it. mannitol-image For Urologic Irrigation A 2.5% solution is used.
The use of 2.5% mannitol solution minimizes the hemolytic effect of water alone, the entrance of hemolyzed blood into the circulation, and the resulting hemoglobinemia which is considered a major factor in producing serious renal complications. PREPARATION OF DILUTIONS FOR UROLOGIC IRRIGATION Concentration How Prepared 2.5% Add contents of two 50 mL vials (25% mannitol) to 900 mL Sterile Water for Injection.
For Intravenous Injection General Recommendations –Give mannitol injection only intravenously. The total dosage, concentration and rate of administration should be governed by the nature and severity of the condition being treated, fluid requirement and urinary output. Usual adult dosage ranges from 50 to 200 g in 24 hours but in most instances an adequate response will be achieved at a dosage of approximately 100 g in 24 hours.
The rate is usually adjusted to…
⛔ Contraindications ▾
CONTRAINDICATIONS • Well established anuria due to severe renal disease. • Severe pulmonary congestion or frank pulmonary edema. • Active intracranial bleeding except during craniotomy. • Severe dehydration. • Progressive renal damage or dysfunction after institution of mannitol therapy, including increasing oliguria and azotemia. • Progressive heart failure or pulmonary congestion after mannitol therapy is started.
⚠️ Warnings ▾
WARNINGS In severe impairment of renal function a test dose should be given (see DOSAGE AND ADMINISTRATION ). A second test dose may be given if there is an inadequate response. No more than two test doses should be attempted.
Excessive loss of water and electrolytes may lead to serious imbalances. Serum sodium and potassium should be carefully monitored during mannitol therapy. The diuresis after rapid infusion of mannitol may increase preexisting hemoconcentration.
With continued use of mannitol a loss of water in excess of electrolytes can cause hypernatremia. Shift of sodium-free intracellular fluid into the extracellular compartment after mannitol infusion may lower serum sodium concentration and aggravate preexisting hyponatremia. Closely monitor the urine output and discontinue mannitol infusion promptly if output is low.
Inadequate urine output results in accumulation of mannitol, expansion of extracellular fluid volume and could result in water intoxication or congestive heart failure. Renal function must be closely monitored during mannitol infusion. Mannitol solution must be used with caution in patients with significant cardiopulmonary or renal dysfunction.
Irrigating solutions used in transurethral prostatectomy have been shown to enter the systemic circulation in relatively large volumes, exert a systemic effect and may significantly alter cardiopulmonary and renal dynamics.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Reactions are infrequent and may include: To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Metabolic: fluid and electrolyte imbalance, acidosis, dehydration. Gastrointestinal: dryness of mouth, nausea, vomiting, diarrhea.
Genitourinary: osmotic nephrosis, urinary retention. Central Nervous System: headache, convulsions, dizziness. Special Senses: Blurred vision, rhinitis.
Cardiovascular: pulmonary edema, edema, hypotension, hypertension, tachycardia, angina-like chest pains. Dermatologic: skin necrosis, thrombophlebitis. Hypersensitivity: urticaria.
Miscellaneous: thirst, arm pain, chills, fever.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mannitol is an osmotic diuretic. After intravenous injection it is confined to the extracellular space, metabolized only slightly and excreted rapidly by the kidneys. Approximately 80% of a 100 g dose appears in the urine in three hours.
Mannitol is freely filtered by the glomeruli with less than 10% tubular reabsorption. It is not secreted by tubular cells. It induces diuresis by elevating the osmolarity of the glomerular filtrate and thereby hinders tubular reabsorption of water.
Urinary output of water and excretion of sodium and chloride are enhanced. Mannitol is poorly absorbed from the gastrointestinal tract. Mannitol injection is free of electrolytes and is used in urology as a nonhemolytic irrigant.
The amount of mannitol absorbed intravascularly during transurethral prostatic surgery is variable and depends primarily on the extent of the surgery. Such mannitol is excreted by the kidneys and produces osmotic diuresis.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Mannitol Injection, USP, 25% Product Code Unit of Sale Strength Each 1550 NDC 63323-024-25 Unit of 25 250 mg per mL NDC 63323-024-01 50 mL Single Dose Flip-off Top Vial Use only if solution is clear and seal intact and undamaged. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preservative Free. Discard unused portion.
📋 Description ▾
DESCRIPTION Mannitol is a 6-carbon sugar alcohol and has the following structure: C 6 H 14 O 6 182.17 Mannitol occurs naturally in fruits and vegetables, and is metabolically inert in humans. Mannitol Injection, USP, 25%, an osmotic diuretic, is a sterile, nonpyrogenic solution of mannitol in Water for Injection. It is a supersaturated solution at room temperature.
Each mL contains: Mannitol 250 mg; Water for Injection q.s. The osmolar concentration is 1372 mOsmol/L (calc.). It contains no antimicrobial agents.
The pH of a 5% solution is between 4.5 and 7.0. mannitol-structure