Premasol - sulfite-free (Amino Acid) LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE 1.4 g/100mL; .82 g/100mL; .82 g/100mL; .78 g/100mL; .48 g/100mL; .48 g/100mL; .42 g/100mL; .34 g/100mL; .2 g/100mL; .24 g/100mL; 1.2 g/100mL Injection, Solution, 500 mL
🆔 Identity & classification
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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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UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
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UNII N762921K75
A colorless, odorless gas that makes up most of the air we breathe. In medicines, it's used as a packaging gas or propellant to protect products from oxidation and maintain freshness.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
3 inactive ingredients listed in the exact product block matched to this NDC.
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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
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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 | $0.1247 | $62.35 / 500 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.1097 | $54.85 / 500 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Premasol - sulfite-free (Amino Acid) 1.4 g/100mL; .82 g/100mL; .82 g/100mL; .78 g/100mL; .48 g/100mL; .48 g/100mL; .42 g/100mL; .34 g/100mL; .2 g/100mL; .24 g/100mL; 1.2 g/100mLthis 00338-1130-03 | Baxter | 500 ml | — | — | 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
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00338-1130-03 You're viewing this | 500 mL in 1 BAG (0338-1130-03) | 2003-06-19 | Active |
| 00338-1130-04 | 1000 mL in 1 BAG (0338-1130-04) | 2003-06-19 | Active |
| 00338-1130-06 | 2000 mL in 1 BAG (0338-1130-06) | 2003-06-19 | Active |
You're viewing the smallest of 3 pack sizes for this product.
This pack accounts for about 6.5% of this product's recent Medicaid fills; most go to the 2 ml pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 00338-1130-03?
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What NDC number is used to bill for this package of Premasol - sulfite-free (Amino Acid) LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE 1.4 g/100mL; .82 g/100mL; .82 g/100mL; .78 g/100mL; .48 g/100mL; .48 g/100mL; .42 g/100mL; .34 g/100mL; .2 g/100mL; .24 g/100mL; 1.2 g/100mL 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) | ✓ 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
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
Pharmacy Bulk Package Not for Direct Infusion
🎯 Indications and Usage ▾
INDICATIONS AND USAGE PREMASOL 10% injection is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with PREMASOL 10% injection is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns.
Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance (see DOSAGE AND ADMINISTRATION ). Central Venous Nutrition Central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted infants, or those requiring long-term parenteral nutrition.
Peripheral Parenteral Nutrition For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5-10% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The objective of nutritional management of infants and young children is the provision of sufficient amino acid and caloric support for protein synthesis and growth. The total daily dose of PREMASOL 10% injection depends on daily protein requirements and on the patient's metabolic and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements.
Dosage should also be guided by the patient's fluid intake limits and glucose and nitrogen tolerances, as well as by metabolic and clinical response. Recommendations for allowances of protein in infant nutrition have ranged from 2 to 4 grams of protein per kilogram of body weight per day (2.0 to 4.0 g/kg/day) Suskind RM: Textbook of Pediatric Nutrition, Raven Press, New York, 1981. . The recommended dosage of PREMASOL 10% injection is 2.0 to 2.5 grams of amino acids per kilogram of body weight per day (2.0 to 2.5 g/kg/day) for infants up to 10 kilograms.
For infants and young children larger than 10 kilograms, the total dosage of amino acids should include the 20 to 25 grams/day for the first 10 kg of body weight plus 1.0 to 1.25 g/day for each kg of body weight over 10 kilograms. Typically, PREMASOL 10% injection is admixed with 50% or 70% Dextrose Injection USP supplemented with electrolytes and vitamins and administered continuously over a 24 hour period. Total daily fluid intake should be appropriate for the patient's age and size.
A fluid dose of 125 mL per kilogram body weight per day is appropriate for most infants on TPN. Although nitrogen requirements may be higher in severely hypercatabolic or depleted patients, provision of additional nitrogen may not be possible due to fluid intake limits, nitrogen, or glucose intolerance. Cysteine is considered to be an essential amino acid in infants and young children.
An admixture of cysteine hydrochloride to the TPN solution is therefore recommended. Based on clinical studies, the recommended dosage is 1.0 mmol of L-cysteine hydrochloride monohydrate per kilogram of body weight per day. In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria.
To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose solutions are abruptly discontinued. 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). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat free TPN.
The provision of sufficient intracellular electrolytes, principally potassium, magnesium, and phosphate, is required for optimum utilization of amino acids. In addition, sufficient quantities of the major extracellular electrolytes sodium, calcium, and chloride, must be given. In patients with hyperchloremic or other metabolic acidosis, sodium and potassium may be added as the acetate salts to provide bicarbonate precursor.
The electrolyte content of PREMASOL 10% injection must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently. Appropriate vitamins, minerals and trace elements should also be provided.
Central Venous Nutrition. Hypertonic mixtures of amino acids and dextrose may be safely administered by continuous infusion through a central venous catheter with the tip located in the superior vena cava. Initial infusion rates should be slow, and gradually increased to the recommended 60-125 mL per kilogram of body weight per day.
If administration rate should fall behind schedule, no attempt to “catch up” to planned intake should be made. In addition to meeting protein needs, the rate of administration, particularly d…
⛔ Contraindications ▾
CONTRAINDICATIONS PREMASOL 10% injection is contraindicated in patients with untreated anuria, hepatic coma, inborn errors of amino acid metabolism, including those involving branched chain amino acid metabolism such as maple syrup urine disease and isovaleric acidemia, or hypersensitivity to one or more amino acids present in the solution.
⚠️ Warnings ▾
WARNINGS This injection is for compounding only, not for direct infusion. Safe, effective use of parenteral nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. Frequent evaluation and laboratory determinations are necessary for proper monitoring of parenteral nutrition.
Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, hemogram, carbon dioxide content, serum osmolalities, blood cultures, and blood ammonia levels. Administration of amino acids in the presence of impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. Patients with azotemia from any cause should not be infused with amino acids without regard to total nitrogen intake.
Administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the solutions.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. Hyperammonemia is of special significance in infants as its occurrence in the syndrome caused by genetic metabolic defects is sometimes associated, although not necessarily in a causal relationship, with mental retardation. This reaction appears to be dose related and is more likely to develop during prolonged therapy.
It is essential that blood ammonia be measured frequently in infants. The mechanisms of this reaction are not clearly defined but may involve genetic defects and immature or subclinically impaired liver function. Conservative doses of amino acids should be given, dictated by the nutritional status of the patient.
Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and 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 See WARNINGS and Special Precautions for Central Venous Nutrition . Reactions reported in clinical studies as a result of infusion of the parenteral fluid were water weight gain, edema, increase in BUN, and mild acidosis. Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.
Local reaction at the infusion site, consisting of a warm sensation, erythema, phlebitis and thrombosis, have been reported with peripheral amino acid infusions, especially if other substances are also administered through the same site. If electrolyte supplementation is required during peripheral infusion, it is recommended that additives be administered throughout the day in order to avoid possible venous irritation. Irritating additive medications may require injection at another site and should not be added directly to the amino acid infusate.
Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with cramps, tetany and muscular hyperexcitability.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
🆘 Overdosage ▾
OVERDOSAGE In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition, and institute appropriate corrective treatment.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY PREMASOL 10% injection provides a mixture of essential and nonessential amino acids as well as taurine and a soluble form of tyrosine, N-Acetyl-L-Tyrosine (NAT). This amino acid composition has been specifically formulated to provide a well tolerated nitrogen source for nutritional support and therapy for infants and young children. When administered in conjunction with cysteine hydrochloride, 10% Amino Acid Injections result in the normalization of the plasma amino acid concentrations to a profile consistent with that of a breast-fed infant.
The rationale for a 10% amino acids injection is based on the observation of inadequate levels of essential amino acids in the plasma of infants receiving total parenteral nutrition (TPN) using conventional amino acid solutions. These formulas were developed through the application of specific pharmacokinetic multiple regression analysis relating amino acid intake to the resulting plasma amino acid concentrations. Clinical studies in infants and young children who required TPN therapy showed that infusion of a 10% amino acids injection with a cysteine hydrochloride admixture resulted in a normalization of the plasma amino acid concentrations.
In addition, weight gains, nitrogen balance, and serum protein concentrations were consistent with an improving nutritional status. When infused with hypertonic dextrose as a calorie source, supplemented with cysteine hydrochloride, electrolytes, vitamins, and minerals, PREMASOL 10% injection provides total parenteral nutrition in infants and young children, with the exception of essential fatty acids. It is thought that the acetate from lysine acetate and acetic acid, under the conditions of parenteral nutrition, does not impact net acid-base balance when renal and respiratory functions are normal.
Clinical evidence seems to support this thinking; however, confirmatory experimental evidence is not available. The amount of chloride present in PREMASOL 10% injection is not of clinical significance. The addition of cysteine hydrochloride will contribute to the chloride load.
The electrolyte content of any additives that are introduced should be carefully considered and included in total input computations.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED PREMASOL 10% - sulfite-free (amino acids) injection is supplied in VIAFLEX plastic Pharmacy Bulk Package containers in the following sizes and concentrations: 500 mL 1000 mL 2000 mL 10% 2B0012 2B0009 2B0010 NDC 0338-1130-03 NDC 0338-1130-04 NDC 0338-1130-06 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 (25°C/77°F). Brief exposure up to 40°C/104°F does not adversely affect the product. Protect from light until immediately prior to use.
Do not remove container from overpouch until ready to use. Do not use if overpouch has been previously opened or damaged.
📋 Description ▾
DESCRIPTION PREMASOL 10% injection is a sterile, nonpyrogenic, hypertonic solutions containing crystalline amino acids provided in a Pharmacy Bulk Package. 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 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. 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, at not more than 0.2 part per million); however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
Intravenous fat emulsion should not be administered in polyvinyl chloride (PVC) containers that use di-2-ethylhexyl phthalate (DEHP) as a plasticizer, because the fat emulsion facilitates the leaching of DEHP from these containers. Each 100 mL contains: Essential Amino Acids 10% Leucine - (CH 3 ) 2 CHCH 2 CH (NH 2 ) COOH 1.4 g Isoleucine - CH 3 CH 2 CH (CH 3 ) CH (NH 2 ) COOH 0.82 g Lysine (added as Lysine Acetate) - H 2 N (CH 2 ) 4 CH (NH 2 ) COOH 0.82 g Valine - (CH 3 ) 2 CHCH (NH 2 ) COOH 0.78 g Histidine Holt LE, Snyderman SE: The amino acid requirements of infants.
JAMA 1961; 175(2):124-127. - (C 3 H 3 N 2 ) CH 2 CH (NH 2 ) COOH 0.48 g Phenylalanine - (C 6 H 5 ) CH 2 CH (NH 2 ) COOH 0.48 g Threonine - CH3CH (OH) CH (NH 2 ) COOH 0.42 g Methionine - CH 3 S (CH 2 ) 2 CH (NH 2 ) COOH 0.34 g Tyrosine (added as Tyrosine and N-Acetyl-L-Tyrosine) - [C 6 H 4 (OH)] CH 2 CH (NH 2 ) COOH 0.24 g Tryptophan - (C 8 H 6 N) CH 2 CH (NH 2 ) COOH 0.20 g Cysteine (added as Cysteine HCl·H 2 O) - SHCH 2 CHNH 2 COOH <0.016 g Nonessential Amino Acids Arginine - H 2 NC (NH) NH (CH 2 ) 3 CH (NH 2 ) COOH 1.2 g Proline – [(CH 2 ) 3 NHCH] COOH 0.68 g Alanine – CH 3 CH (NH 2 ) COOH 0.54 g Glutamic Acid – HOOC (CH 2 ) 2 CH (NH 2 ) COOH 0.50 g Serine - HOCH 2 CH (NH 2 ) COOH 0.38 g Glycine - H 2 NCH 2 COOH 0.36 g Aspartic Acid – HOOC CH 2 CH (NH 2 ) COOH 0.32 g Taurine Rigo J, Senterre J: Is taurine essential for the neonates?
Biol Neonate 1977; 32:73-76. Gaull G, Sturman JA, Raiha NCR: Development of mammalian sulfur metabolism: Absence of cystothionase in human fetal tissues. Pediatr Res 1972: 6:538-547. - H 2 NCH 2 CH 2 SO 3 H 0.025 g pH adjusted with glacial acetic acid pH: 5.5 (5.0-6.0) Osmolarity (mOsmol/L) (Calc.) 865 Total Amino Acids (grams/100 mL) (Calc.) 10 Total Nitrogen (grams/100 mL) (Calc.)
1.55Acetate * - (CH 3 COO-) 94 mEq/L Chloride (Calc.) <3 mEq/L *Provided as acetic acid and lysine acetate. All amino acids are added as the “L”-isomer with the exception of Glycine and Taurine, which do not have isomers.