Clinisol Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine 1.18 g/100mL; 1.04 g/100mL; 1.04 g/100mL; 960 mg/100mL; 894 mg/100mL; 749 mg/100mL; 749 mg/100mL; 749 mg/100mL; 250 mg/100mL; 2.17 g/100mL; 1 Injection, Solution, 2000 mL
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
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Supplement & herbal interactions
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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.
Where does this data come from?
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 | $0.2043 | $408.60 / 2000 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.0621 | $124.20 / 2000 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Plenamine 1.18 g/100mL; 1.04 g/100mL; 1.04 g/100mL; 960 mg/100mL; 749 mg/100mL; 749 mg/100mL; 749 mg/100mL; 250 mg/100mL; 2.17 g/100mL; 1.47 g/100mL; 1.0 00264-4500-00 | B. | 1000 ml | — | — | FDA listed | — |
| Clinisol 1.18 g/100mL; 1.04 g/100mL; 1.04 g/100mL; 960 mg/100mL; 894 mg/100mL; 749 mg/100mL; 749 mg/100mL; 749 mg/100mL; 250 mg/100mL; 2.17 g/100mL; 1this 00338-0502-06 | Baxter | 2000 ml | — | — | 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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00338-0502-03 | 500 mL in 1 BAG (0338-0502-03) | 1996-08-30 | Active |
| 00338-0502-06 You're viewing this | 2000 mL in 1 BAG (0338-0502-06) | 1996-08-30 | Active |
You're viewing the largest of 2 pack sizes for this product.
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00338-0502-06?
What is the difference between NDC 00338-0502-06 and NDC 00338-0502-03?
What NDC number is used to bill for this package of Clinisol Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine 1.18 g/100mL; 1.04 g/100mL; 1.04 g/100mL; 960 mg/100mL; 894 mg/100mL; 749 mg/100mL; 749 mg/100mL; 749 mg/100mL; 250 mg/100mL; 2.17 g/100mL; 1 Injection, 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) | — 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 | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| 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 |
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?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Doses which achieve nitrogen equilibrium or positive balance are the most desirable. The dosage on the first day should be approximately half the anticipated optimal dosage and should be increased gradually to minimize glycosuria; similarly, withdrawal should be accomplished gradually to avoid rebound hypoglycemia. Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD).
Pediatric Use: Use of 15% CLINISOL - sulfite-free (Amino Acid) Injection in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance.
Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. A slight yellow color does not alter the quality and efficacy of this product.
Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used.
Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly.
Do not store any unused portion of 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package. Central Vein Infusion In unstressed adult patients with no unusual nitrogen losses, a minimum dosage of 0.1 gram nitrogen (4.2 mL of 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package) plus 4.4 grams (15 calories) of dextrose/fat emulsion per kilogram of body weight per day is required to achieve nitrogen balance and weight stability. For patients stressed by surgery, trauma or sepsis, and those with unusual nitrogen losses, the dosage required for maintenance may be as high as 0.3 to 0.4 grams of nitrogen (13 to 17 mL 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package) per kilogram of body weight per day, with proportionate increases in non-protein calories.
Periodic assessment of nitrogen balance of the individual patient is the best indicator of proper dosage. Use of an infusion pump is advisable to maintain a steady infusion rate during central venous infusion. Peripheral Infusion In patients for whom central vein catheterization is not advisable, admixtures with 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package can be administered by peripheral vein.
Dilution of 250 mL 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package in 750 mL of 10% dextrose will reduce the osmolarity to a level (718 mOsmol/L) which is more favorable to the maintenance of the integrity of the walls of the veins. If infused simultaneously, fat emulsion will provide a dilution effect upon the osmolarity, as well. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).
⛔ Contraindications ▾
CONTRAINDICATIONS Hypersensitivity to one or more amino acids Severe liver disease or hepatic coma Anuria Metabolic disorders involving impaired nitrogen utilization
⚠️ Warnings ▾
WARNINGS Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic techniques.
Mix thoroughly. Do not store. Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture.
This injection is for compounding only, not for direct infusion. Once container closure has been penetrated, withdrawal of contents should be completed within 4 hours. After initial entry, maintain contents at room temperature (25ºC/77ºF).
Any admixture storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours. Administration of amino acid solutions at excessive rates or to patients with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. Conservative doses of amino acids should be given to these patients, dictated by the nutritional status of the patient.
Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient's clinical status reevaluated. 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 μg/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 Local reactions consisting of a warm sensation, erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous infusion of amino acids. In such cases the infusion site should be changed promptly to another vein. Generalized flushing, fever and nausea also have been reported during peripheral infusions of amino acid solutions.
The following metabolic complications have been reported with administration of TPN: metabolic acidosis and alkalosis, hypophosphatemia, hypocalcemia, osteoporosis, glycosuria, hyperglycemia, hyperosmolar nonketotic states and dehydration, rebound hypoglycemia, osmotic diuresis and dehydration, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances, hyperammonemia, coma and death. Sepsis has been reported following intravenous therapy, especially when using central venous catheters for prolonged periods.
Complications known to occur from the placement of central venous catheters are pneumothorax, hemothorax, hydrothorax, artery puncture and transection injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis and air and catheter emboli.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects Animal reproduction studies have not been conducted with 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package. It is also not known whether 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness of 15% CLINISOL - sulfite-free (Amino Acid) Injection in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acid injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature. See Dosage and Administration .
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package administered parenterally will provide biologically utilizable source material for protein synthesis when used with concentrated calorie sources, electrolytes, vitamins and minerals. Central Infusion 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is intended for use in a pharmacy admixture program and as such is restricted to the preparation of admixtures for intravenous use. 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package given by central venous infusion in combination with energy sources, vitamins, trace elements and electrolytes, will meet the requirements for weight maintenance or weight gain.
The energy component may be derived solely from dextrose or may be provided by a combination of dextrose and intravenous fat emulsion. Peripheral Infusion 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package, when diluted to an appropriate osmolarity level (718 mOsmol/L) can also be administered by a peripheral vein when use of a central venous catheter is contraindicated.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is available in VIAFLEX plastic containers as follows. 2B6187 500 mL NDC 0338-0502-03 2B6189 2000 mL NDC 0338-0502-06 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF).
📋 Description ▾
DESCRIPTION 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is a sterile, clear, nonpyrogenic, hypertonic solution of essential and nonessential amino acids. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.
The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25ºC/77ºF 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. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological test for plastic containers as well as by tissue culture toxicity studies.
Each 100 mL of 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package contains: Amino Acids Total Nitrogen pH 15.0 g 2.37 g 6.0 (5.0 to 7.0) (pH adjusted with glacial acetic acid) Essential Amino Acids Lysine - (from Lysine Acetate) C 6 H 14 N 2 O 2 Leucine - C 6 H 13 NO 2 Phenylalanine – C 9 H 11 NO 2 Valine - C 5 H 11 NO 2 Histidine - C 6 H 9 N 3 O 2 Isoleucine - C 6 H 13 NO 2 Methionine - C 5 H 11 NO 2 S Threonine - C 4 H 9 NO 3 Tryptophan - C 11 H 12 N 2 O 2 Nonessential Amino Acids Alanine - C 3 H 7 NO 2 Arginine - C 6 H 14 N 4 O 2 Glycine - C 2 H 5 NO 2 Proline - C 5 H 9 NO 2 Glutamic Acid - C 5 H 9 NO 4 Serine – C 3 H 7 NO 3 Aspartic Acid – C 4 H 7 NO 4 Tyrosine – C 9 H 11 NO 3 Anion profiles per liter* Acetate from Lysine Acetate and glacial acetic acic *Balanced by ions from amino acids Osmolarity (Calc.) 1.18 g 1.04 g 1.04 g 960 mg 894 mg 749 mg 749 mg 749 mg 250 mg 2.17 g 1.47 g 1.04 g 894 mg 749 mg 592 mg 434 mg 39 mg 127 mEq 1357 mOsmol/L