Chlorothiazide 500 mg/18mL Injection, Powder, Lyophilized, For Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Thiazide Diuretic class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
- It's a water pill — it helps your kidneys flush out extra salt and fluid that's building up in your body. Depending on the form you're taking, it treats fluid retention (edema) fro...
- What exactly is chlorothiazide supposed to do for me?
- You'll take it by mouth, usually once or twice a day. Your doctor might also put you on an every-other-day or a few-days-per-week schedule — that actually helps prevent your electr...
- How and when should I take the oral suspension (liquid)?
Patient education
Supplement & herbal interactions
Chlorothiazide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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250 mg / 18 mL
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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
Are inactive ingredients the same for every manufacturer?
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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. | |
| Medicare Part B allowsASP · J1205 | $77.771 / J1205 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Chlorothiazide Sodium 500 mg/18mL 00517-1820-01 | American | 1 vial | — | AP | FDA listed | — |
| chlorothiazide sodium 500 mg/18mL 25021-0305-66 | Sagent | 1 vial | — | AP | FDA listed | — |
| Chlorothiazide Sodium 500 mg/18mL 47335-0330-40 | Sun | 1 vial | — | AP | FDA listed | — |
| Chlorothiazide 500 mg/18mLthis 63323-0658-27 | Fresenius | 1 vial | — | AP | FDA listed | — |
| Chlorothiazide sodium 500 mg/18mL 68083-0614-01 | Gland | 1 vial | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63323-0658-27 You're viewing this | 1 VIAL in 1 BOX (63323-658-27) / 18 mL in 1 VIAL | 2009-10-21 | Active |
| 63323-0658-20 | 1 VIAL in 1 BOX (63323-658-20) / 18 mL in 1 VIAL | 2009-10-21 | Active |
| 63323-0658-94 | 1 VIAL in 1 BOX (63323-658-94) / 18 mL in 1 VIAL | 2009-10-21 | Active |
Pack size FAQ
What quantity is in NDC 63323-0658-27?
What NDC number is used to bill for this package of Chlorothiazide 500 mg/18mL Injection, Powder, Lyophilized, For 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 | ✓ Available |
| 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 | ✓ Available |
| 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
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Is the NDC printed on the package the same as the 11-digit billing NDC?
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Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Does this product have a billing J-code?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: Chlorothiazide sodium for injection is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide sodium for injection has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Use in Pregnancy Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard.
Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS , Pregnancy ).
Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia, which is not harmful to the fetus or the mother in the absence of cardiovascular disease.
However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest.
In these instances, a short course of diuretic therapy may provide relief and be appropriate.
Use in Pregnancy Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy.
Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS , Pregnancy ). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary.
During normal pregnancy there is hypervolemia, which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief.
Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Chlorothiazide sodium for injection should be reserved for patients unable to take oral medication or for emergency situations. Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.
Intravenous use in infants and children has been limited and is not generally recommended. When medication can be taken orally, therapy with chlorothiazide tablets or oral suspension may be substituted for intravenous therapy, using the same dosage schedule as for the parenteral route. Chlorothiazide sodium for injection may be given slowly by direct intravenous injection or by intravenous infusion.
Extravasation must be rigidly avoided. Do not give subcutaneously or intramuscularly. The usual adult dosage is 500 mg to 1 g once or twice a day.
Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur. Directions for Reconstitution Use aseptic technique.
Because chlorothiazide sodium for injection contains no preservative, a fresh solution should be prepared immediately prior to each administration, and the unused portion should be discarded. Add 18 mL of Sterile Water for Injection to the vial to form an isotonic solution for intravenous injection. Never add less than 18 mL.
When reconstituted with 18 mL of Sterile Water, the final concentration of intravenous chlorothiazide sodium is 28 mg/mL. The reconstituted solution is clear and essentially free from visible particles. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit.
The solution is compatible with dextrose or sodium chloride solutions for intravenous infusion. Avoid simultaneous administration of solutions of chlorothiazide with whole blood or its derivatives.
Directions for Reconstitution Use aseptic technique. Because chlorothiazide sodium for injection contains no preservative, a fresh solution should be prepared immediately prior to each administration, and the unused portion should be discarded. Add 18 mL of Sterile Water for Injection to the vial to form an isotonic solution for intravenous injection.
Never add less than 18 mL. When reconstituted with 18 mL of Sterile Water, the final concentration of intravenous chlorothiazide sodium is 28 mg/mL. The reconstituted solution is clear and essentially free from visible particles.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit. The solution is compatible with dextrose or sodium chloride solutions for intravenous infusion. Avoid simultaneous administration of solutions of chlorothiazide with whole blood or its derivatives.
⛔ Contraindications ▾
CONTRAINDICATIONS: Anuria. Hypersensitivity to any component of this product or to other sulfonamide-derived drugs.
⚠️ Warnings ▾
WARNINGS: Intravenous use in infants and children has been limited and is not generally recommended. Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia.
Cumulative effects of the drug may develop in patients with impaired renal function. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Thiazides may add to or potentiate the action of other antihypertensive drugs.
Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. Lithium generally should not be given with diuretics (see PRECAUTIONS , Drug Interactions ) .
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity. Body as a Whole - Weakness. Cardiovascular - Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs).
Digestive - Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia. Hematologic - Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia. Hypersensitivity - Anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura.
Metabolic - Electrolyte imbalance (see PRECAUTIONS ), hyperglycemia, glycosuria, hyperuricemia. Musculoskeletal - Muscle spasm. Nervous System/Psychiatric - Vertigo, paresthesias, dizziness, headache, restlessness.
Skin - Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia. Special Senses - Transient blurred vision, xanthopsia. Renal - Renal failure, renal dysfunction, interstitial nephritis, (see WARNINGS ); hematuria (following intravenous use).
Urogenital - Impotence. Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.
🆘 Overdosage ▾
OVERDOSAGE: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. In the event of overdosage, symptomatic and supportive measures should be employed.
Correct dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. If required, give oxygen or artificial respiration for respiratory impairment. The degree to which chlorothiazide sodium is removed by hemodialysis has not been established.
The intravenous LD 50 of chlorothiazide in the mouse is 1.1 g/kg.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: The mechanism of the antihypertensive effect of thiazides is unknown. Chlorothiazide does not usually affect normal blood pressure. Chlorothiazide affects the distal renal tubular mechanism of electrolyte reabsorption.
At maximal therapeutic dosage all thiazides are approximately equal in their diuretic efficacy. Chlorothiazide increases excretion of sodium and chloride in approximately equivalent amounts. Natriuresis may be accompanied by some loss of potassium and bicarbonate.
After oral use diuresis begins within 2 hours, peaks in about 4 hours and lasts about 6 to 12 hours. Following intravenous use of chlorothiazide sodium, onset of the diuretic action occurs in 15 minutes and the maximal action in 30 minutes. Pharmacokinetics and Metabolism Chlorothiazide is not metabolized but is eliminated rapidly by the kidney; 96 percent of an intravenous dose is excreted unchanged in the urine within 23 hours.
The plasma half-life of chlorothiazide is 45 to 120 minutes. Chlorothiazide crosses the placental but not the blood-brain barrier and is excreted in breast milk.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Chlorothiazide Sodium for Injection, USP is a dry, sterile lyophilized powder, supplied as follows: Product Code Unit of Sale Strength Each NP605820 NDC 63323-658-27 Individually Packaged 500 mg per vial NDC 63323-658-27 Single Dose Vial The container closure is not made with natural rubber latex. Storage STORE LYOPHILIZED POWDER BETWEEN: 2 ° and 25 °C ( 36 ° and 77 °F). For single dose only.
Use solution immediately after reconstitution. (See DOSAGE AND ADMINISTRATION , Directions for Reconstitution .) Discard unused portion of the reconstituted solution. NOVAPLUS is a registered trademark of Vizient, Inc.
Storage STORE LYOPHILIZED POWDER BETWEEN: 2 ° and 25 °C ( 36 ° and 77 °F). For single dose only. Use solution immediately after reconstitution. (See DOSAGE AND ADMINISTRATION , Directions for Reconstitution .) Discard unused portion of the reconstituted solution. NOVAPLUS is a registered trademark of Vizient, Inc.
📋 Description ▾
DESCRIPTION: Chlorothiazide sodium for injection, USP is a diuretic and antihypertensive. It is 6-chloro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt, and its structural formula is: C 7 H 5 ClN 3 NaO 4 S 2 M.W. 317.71 Chlorothiazide sodium for injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide 500 mg, and the inactive ingredient mannitol 250 mg with sodium hydroxide to adjust pH.
Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide, and its structural formula is: C 7 H 6 ClN 3 O 4 S 2 M.W. 295.72 It is a white, or practically white, crystalline powder, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide.
It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7. structure 1 structure 2