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ProSol Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and Tyrosine 1.44 g/100mL; 1.35 g/100mL; 1.18 g/100mL; 1.08 g/100mL; 1.08 g/100mL; 1 g/100mL; 980 mg/100mL; 760 mg/100mL; 320 mg/100mL; 2.76 g/100mL; 2.06 Injection, Solution, 2000 mL — NDC 00338-0499-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ProSol Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and Tyrosine 1.44 g/100mL; 1.35 g/100mL; 1.18 g/100mL; 1.08 g/100mL; 1.08 g/100mL; 1 g/100mL; 980 mg/100mL; 760 mg/100mL; 320 mg/100mL; 2.76 g/100mL; 2.06 Injection, Solution, 2000 mL — NDC 0338-0499-06 (Billing 00338-0499-06)

by Baxter Healthcare Corporation · 2000 mL in 1 BAG

This is a package of 2,000 mL of ProSol Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and Tyrosine 1.44 g/100mL; 1.35 g/100mL; 1.18 g/100mL; 1.08 g/100mL; 1.08 g/100mL; 1 g/100mL; 980 mg/100mL; 760 mg/100mL; 320 mg/100mL; 2.76 g/100mL; 2.06 Injection, Solution from Baxter Healthcare Corporation, marketed since Aug 1998 and currently FDA-listed. It is this product's only package size.

NDC 00338-0499-06
🏷️ FDA NDC (as labeled) 0338-0499-06 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⚠ On shortage ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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NDC database record

One package, one record: these facts belong to NDC 0338-0499-06 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0338 labeler · 0499 product · 06 package
Package marketed since
Aug 26, 1998
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
2,000 mL per package
Barcode (UPC-A, from the NDC)
3 0338049906 9
Medicaid fills, this package
6,987 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026
⚠️
Active FDA shortage. Amino Acid Injection is currently reported in shortage by the FDA. Available Shortage details →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0338-0499-06
Product NDC 0338-0499
11-digit billing NDC 00338049906
NCPDP billing unit ML — per mL (volume)
Application # NDA020849
SPL Set ID cc2ace81-5881-43f1-ba94-41b674adc2fc
Established class (EPC) Amino Acid
Chemical class Amino Acids
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1998-08-26
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance VALINE; LYSINE ACETATE; HISTIDINE; ISOLEUCINE; LEUCINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 063247
GCN 99000
HICL code 035084
Ingredient (HICL) Parenteral Amino Acid 20% No.1
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C9
Therapeutic class — intermediate (HIC2) Carbohydrates And/Or Proteins (Continued 1)
HIC3 code C9C
Therapeutic class — specific (HIC3) Parenteral Amino Acid Solutions And Combinations
AHFS code 40:20.00.00
AHFS class Caloric Agents
FDB label name PROSOL 20% INJECTION
FDB brand name Prosol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 063247
  • GCN: 99000
  • HICL (First Databank): 035084
  • AHFS class code: 40:20.00.00
Why two NDCs? The FDA registers this code as 0338-0499-06 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00338-0499-06. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name PROSOL 20% INJECTION Ingredient Parenteral Amino Acid 20% No.1

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.0478 $95.60 / 2000 ml
Medicare drug plans payPart D · Q2 2026 $0.0829 $165.80 / 2000 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00338-0499-06 You're viewing this Main listing 2000 mL in 1 BAG 1998-08-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ProSol 1.44 g/100mL; 1.35 g/100mL; 1.18 g/100mL; 1.08 g/100mL; 1.08 g/100mL; 1 g/100mL; 980 mg/100mL; 760 mg/100mL; 320 mg/100mL; 2.76 g/100mL; 2.06this 00338-0499-06 Baxter 2000 ml — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1998
On the market since
Aug 1998
📍
2026
Currently FDA-listed
28 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

  • 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.
  • 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.
  • 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.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBaxter Healthcare Corporation
Application holderBAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV
FDA applicationNDA020849 (NDA)
Labeler code00338
First marketedAug 1998
Product typeHuman Prescription Drug
Portfolio283 products on file

More NDCs from Baxter Healthcare Corporation labeler code 00338

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 80 words ▾

1 INDICATIONS AND USAGE PROSOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PROSOL may be used to treat negative nitrogen balance in patients. • PROSOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PROSOL may be used to treat negative nitrogen balance in patents.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Pharmacy Bulk Package. Not for direct intravenous infusion. ( 2.1 ) • See full prescribing information for information on preparation, administration, instructions for use, dosing considerations, including the recommended dosage in adults and pediatrics, and dosage modifications in patients with renal impairment.

( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 ) • Protect the admixed parenteral nutrition solution from light. ( 2.3 )

2.1Important Preparation Information PROSOL is supplied as a pharmacy bulk package for admixing only and is not for direct intravenous infusion . Prior to administration, PROSOL must be transferred to a separate parenteral nutrition container, diluted and used as an admixture with or without dextrose, electrolytes and/or lipid emulsion. • The key factor in preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients. • Do not remove container from overpouch until ready to use. • Tear protective overpouch across top at slit and remove solution container.

Small amounts of moisture may be found on the solution container from water permeating from inside the container. The amount of permeated water is insufficient to affect the solution significantly. If larger amounts of water are found, the container should be checked for tears or leaks. • Inspect PROSOL prior to use.

Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

Amino acid crystals may be present. Crystals will re-dissolve upon dilution during admixture compounding. Evaluate the following: o If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. o Check to ensure the solution is clear, colorless or slightly yellow.

Discard if the solution is bright yellow or yellowish brown. o Check for minute leaks by squeezing inner container. If leaks are found, discard container. • PROSOL is intended for use in the preparation of sterile, intravenous admixtures. Because additives may be incompatible with PROSOL, evaluate all additions for compatibility.

2.2Administration Instructions PROSOL is for admixing use only. It is not for direct intravenous infusion. Prior to administration, PROSOL must be diluted with other compatible intravenous fluids or used as an admixture with or without dextrose, electrolytes and/or lipid emulsion. • PROSOL is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).

The key factor in the preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients. • PROSOL is for admixing with dextrose injection and/or lipid emulsions using a parenteral nutrition container. • When PROSOL is admixed with dextrose injection and/or lipid emulsion, the choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. Solutions with greater than 5% dextrose or with osmolarity of 900 mOsm/L or greater must be infused through a central venous catheter [see Warnings and Precautions (5.6) ]. • Use a dedicated line for parenteral nutrition solutions. • Intravenous lipid emulsions can be infused concurrently into the same vein as PROSOL -dextrose solutions by a Y-connector located near the infusion site; flow rates of each solution should be controlled separately by infusion pumps. • For administration without lipid emulsion, use a 0.22 micron in-line filter.

If lipid emulsion is also administered, use a 1.2 micron in-line filter. • To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 180 words ▾

3 DOSAGE FORMS AND STRENGTHS PROSOL 20% is a sterile solution of 20 grams of amino acids per 100 mL (0.2 gram/mL) available in 2000 mL flexible containers. Table 3 describes the individual components of PROSOL. Table 3.

Ingredients per 100 mL of PROSOL Amino Acids 20.0 g Total Nitrogen 3.21 g Essential Amino Acids Valine 1.44 g Lysine (added as Lysine Acetate) 1.35 g Histidine 1.18 g Isoleucine 1.08 g Leucine 1.08 g Phenylalanine 1.00 g Threonine 980 mg Methionine 760 mg Tryptophan 320 mg Nonessential Amino Acids Alanine 2.76 g Glycine 2.06 g Arginine 1.96 g Proline 1.34 g Glutamic Acid 1.02 g Serine 1.02 g Aspartic Acid 600 mg Tyrosine 50 mg Anion profiles per liter Balanced by ions from amino acids. Acetate from Lysine Acetate and glacial acetic acid Derived from pH adjustment with glacial acetic acid.

140 mEq pH (Range); pH adjusted with glacial acetic acid 6.0 (5.5 to 6.5) Osmolarity (calc.) 1835 mOsmol/L • Injection: 20% (0.2 grams/mL), 20 grams of amino acids per 100 mL in 2000 mL flexible containers. ( 3 )

⛔ Contraindications 93 words ▾

4 CONTRAINDICATIONS The use of PROSOL is contraindicated in: • Patients with known hypersensitivity to one or more amino acids [see Warnings and Precautions (5.2) ]. • Patients with inborn errors of amino acid metabolism due to risk of severe metabolic or neurologic complications. • Patients with pulmonary edema or acidosis due to low cardiac output. • Known hypersensitivity to one or more amino acids ( 4 ) • Inborn errors of amino acid metabolism ( 4 ) • Patients with pulmonary edema or acidosis due to low cardiac output ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Pulmonary Embolism due to Pulmonary Vascular Precipitates: if signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 ) • Hypersensitivity Reactions: monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.2 ) • Risk of Infections, Refeeding Complications, and Hyperglycemia or Hyperosmolar Hyperglycemic State: monitor for signs and symptoms; monitor laboratory parameters.

( 5.3 , 5.4 , 5.5 ) • Vein Damage and Thrombosis: solutions with osmolarity of 900 mOsmol/L or more must be infused through a central catheter. ( 2.2 , 5.6 ) • Hepatobiliary Disorders: monitor liver function parameters and ammonia levels. ( 5.7 ) • Aluminum Toxicity: increased risk in patients with renal impairment, including preterm infants.

( 5.8 , 8.4 ) • Parenteral Nutrition Associated Liver Disease: increased risk in patients who receive parenteral nutrition for extended periods of time, especially preterm infants; monitor liver function tests, if abnormalities occur consider discontinuation or dosage reduction. ( 5.9 , 8.4 ) • Electrolyte Imbalance and Fluid Overload: patients with cardiac insufficiency or renal impairment may require adjustment of fluid, protein and electrolyte content. ( 5.10 , 8.4 )

5.1Pulmonary Embolism due to Pulmonary Vascular Precipitates Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes due to pulmonary embolism have occurred. PROSOL contains no added phosphorus.

Patients, especially those with hypophosphatemia, may require the addition of phosphate. To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration. Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates.

Precipitates have been reported even in the absence of phosphate salt in the solution. Precipitation following passage through an in-line filter and suspected in vivo precipitate formation has also been reported. If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.

In addition to inspection of the solution [see Dosage and Administration (2.1 , 2.2 , 2.3 , 2.4 )] , the infusion set and catheter should also periodically be checked for precipitates.

5.2Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis have been reported with parenteral nutrition solutions containing PROSOL. Stop the infusion immediately and treat patient accordingly if any signs or symptoms of a hypersensitivity reaction develop. Signs or symptoms may include: hypotension, hypertension, peripheral cyanosis, tachycardia, dyspnea, vomiting, nausea, urticaria, rash, pruritus, erythema, hyperhidrosis, pyrexia, and chills.

5.3Risk of Infections Patients who require parenteral nutrition are at high risk of infections because the nutritional components of these solutions can support microbial growth. Infection and sepsis may also occur as a result of the use of intravenous catheters to administer parenteral nutrition. The risk of infection is increased in patients with malnutrition-associated immunosuppression, hyperglycemia exacerbated by dextrose infusion, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other concomitant conditions, drugs, or other components of the parenteral formulation (e.g., lipid emulsion).

To decrease the risk of infection, ensure aseptic technique in catheter placement and maintenance, as well as aseptic technique in the preparation and administration of the nutritional formula. Monitor for signs and symptoms (including fever and chills) of early infections, including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device and insertion site for edema, redness and discharge.

5.4Refeeding Syndrome Re… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information. • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1) ] • Hypersensitivity reactions [see Warnings and Precautions (5.2) ] • Risk of infections [see Warnings and Precautions (5.3) ] • Refeeding syndrome [see Warnings and Precautions (5.4) ] • Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.5) ] • Vein damage and thrombosis [see Warnings and Precautions (5.6) ] • Hepatobiliary disorders [see Warnings and Precautions (5.7) ] • Aluminum toxicity [see Warnings and Precautions (5.8) ] • Parenteral Nutrition Associated Liver Disease [see Warnings and Precautions (5.9) ] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.10) ] The following adverse reactions from voluntary reports or clinical studies have been reported with parenteral amino acid products.

Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Metabolic acidosis • Alkalosis • Osmotic diuresis and dehydration • Rebound hypoglycemia • Hypo- and hyper-vitaminosis Adverse reactions include pulmonary vascular emboli, hypersensitivity reactions infection, refeeding syndrome, hyperglycemia and hyperosmolar hyperglycemic state, vein thrombosis, elevated liver function tests, hyperammonemia, electrolyte imbalances, and hypervolemia.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatric Use: increased risk of hypoglycemia/hyperglycemia: monitor serum glucose concentrations. ( 8.4)

8.1Pregnancy Risk Summary Limited published data with injectable amino acids solutions, including PROSOL in pregnant women are not sufficient to inform a drug associated risk for adverse developmental outcomes. However, malnutrition in pregnant women is associated with adverse maternal and fetal outcomes [see Clinical Considerations ]. Animal reproduction studies have not been conducted with injectable amino acids solutions, including PROSOL.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. Parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake.

8.2Lactation Risk Summary There are no data available to assess the presence of injectable amino acids, including PROSOL in human milk, the effects of PROSOL on the breastfed infant or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of PROSOL to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PROSOL and any potential adverse effects on the breastfed child from PROSOL or from the underlying maternal condition.

8.4Pediatric Use Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects [see Dosage and Administration (2.7) ]. Plasma electrolyte concentrations should be closely monitored in the pediatric patients who may have impaired ability to regulate fluids and electrolytes. Hyperammonemia is of special significance in infants (birth to two years).

This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants [see Warnings and Precautions (5.7) ]. Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with PROSOL may be at risk of aluminum toxicity [see Warnings and Precautions (5.8) ].

Patients, including pediatric patients, may be at risk for PNALD [see Warnings and Precautions (5.9) ].

8.5Geriatric Use Clinical studies with PROSOL have not been performed to determine whether subjects aged 65 and over respond differently from other younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

8.6Renal Impairment In patients with impaired renal function, parenteral nutrition solutions containing PROSOL should be administered with caution. Frequent clinical evaluation and laboratory tests to monitor renal function such as serum electrolytes (especially phosphate and potassium) and fluid balance should be conducted [see Dosage and Administration (2.6) , and Warnings and Precautions (5.10) ].

8.7Hepatic Impairment In patients wit… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 165 words ▾

8.1Pregnancy Risk Summary Limited published data with injectable amino acids solutions, including PROSOL in pregnant women are not sufficient to inform a drug associated risk for adverse developmental outcomes. However, malnutrition in pregnant women is associated with adverse maternal and fetal outcomes [see Clinical Considerations ]. Animal reproduction studies have not been conducted with injectable amino acids solutions, including PROSOL.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. Parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake.

🧒 Pediatric Use 163 words ▾

8.4Pediatric Use Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects [see Dosage and Administration (2.7) ]. Plasma electrolyte concentrations should be closely monitored in the pediatric patients who may have impaired ability to regulate fluids and electrolytes. Hyperammonemia is of special significance in infants (birth to two years).

This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants [see Warnings and Precautions (5.7) ]. Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with PROSOL may be at risk of aluminum toxicity [see Warnings and Precautions (5.8) ].

Patients, including pediatric patients, may be at risk for PNALD [see Warnings and Precautions (5.9) ].

🧓 Geriatric Use 80 words ▾

8.5Geriatric Use Clinical studies with PROSOL have not been performed to determine whether subjects aged 65 and over respond differently from other younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

🆘 Overdosage 85 words ▾

10 OVERDOSAGE An increased infusion rate of parenteral nutrition can cause hypervolemia, electrolyte disturbances, acidosis and/or azotemia, hyperglycemia, hyperosmolality [see Warnings and Precautions (5.5 , 5.10 )]. Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to respiratory and cardiovascular systems.

For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org .

🧬 Clinical Pharmacology 54 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action PROSOL is used as a supplement of nutrition in patients, providing amino acids parenterally. The amino acids provide the structural units that make up proteins and are used to synthesize proteins and other biomolecules or are oxidized to urea and carbon dioxide as a source of energy.

🧬 Mechanism of Action 51 words ▾

12.1Mechanism of Action PROSOL is used as a supplement of nutrition in patients, providing amino acids parenterally. The amino acids provide the structural units that make up proteins and are used to synthesize proteins and other biomolecules or are oxidized to urea and carbon dioxide as a source of energy.

📦 How Supplied / Storage and Handling 96 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING PROSOL 20% (amino acids) injection is available in plastic Pharmacy Bulk Package flexible containers in the following size as shown in Table 5 below. Table 5. PROSOL Dosage Form Code Volume NDC Number 2B6186 2000 mL NDC 0338-0499-06 Minimize exposure of PROSOL to heat and avoid excessive heat.

Protect from freezing. Store PROSOL at room temperature (25ºC/77ºF). Brief exposure up to 40ºC/104ºF does not adversely affect the product.

Do not use if protective overpouch has been previously opened or damaged. For storage of admixed solutions [see Dosage and Administration (2.3) ].

📋 Description ~1 min read ▾

11 DESCRIPTION PROSOL 20% (amino acids) injection is a sterile, nonpyrogenic, hypertonic solution of essential and nonessential amino acids supplied in a flexible container as 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 [see Dosage and Administration (2.1) ].

PROSOL is not for direct intravenous infusion. The formulas for the individual amino acids found in PROSOL are provided in Table 4 . Table 4.

Formulas for Amino Acids Essential Amino Acids Leucine (CH 3 ) 2 CHCH 2 CH (NH 2 ) COOH Isoleucine CH 3 CH 2 CH (CH 3 ) CH (NH 2 ) COOH Lysine (added as the hydrochloride salt) H 2 N (CH 2 ) 4 CH (NH 2 ) COOH Valine (CH 3 ) 2 CHCH (NH 2 ) COOH Phenylalanine (C 6 H 5 ) CH 2 CH (NH 2 ) COOH Histidine (C 3 H 3 N 2 ) CH 2 CH (NH 2 ) COOH Threonine CH 3 CH (OH) CH (NH 2 ) COO Methionine CH 3 S (CH 2 )2 CH (NH 2 ) COOH Tryptophan (C 8 H 6 N) CH 2 CH (NH 2 ) COOH Nonessential Amino Acids Alanine CH 3 CH (NH 2 ) COOH Arginine H 2 NC (NH) NH (CH 2 )3 CH (NH 2 ) COOH Aspartic Acid HOOC CH 2 CH (NH 2 ) COOH Glutamic Acid HOOC (CH 2 ) 2 CH (NH 2 ) COOH Glycine H 2 NCH 2 COOH Proline [(CH 2 ) 3 NH CH] COOH Serine HOCH 2 CH (NH 2 ) COOH Tyrosine [C 6 H 4 (OH)] CH 2 CH (NH 2 ) COOH PROSOL contains no more than 25 mcg/L of aluminum.

💬 Information for Patients 125 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers, or home healthcare providers of the following risks of PROSOL: • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1) ] • Hypersensitivity reactions [see Warnings and Precautions (5.2) ] • Risk of infections [see Warnings and Precautions (5.3) ] • Refeeding syndrome [see Warnings and Precautions (5.4) ] • Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.5) ] • Vein damage and thrombosis [see Warnings and Precautions (5.6) ] • Hepatobiliary disorders [see Warnings and Precautions (5.7) ] • Aluminum toxicity [see Warnings and Precautions (5.8) ] • Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.9) ] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.10) ]

📚 References 39 words ▾

15 REFERENCES 1. Ayers P. et al. A.S.P.E.N. Parenteral Nutrition Handbook, 2nd ed. 2014 pg. 123 2. Mueller CM ed. The A.S.P.E.N. Nutrition Support Core Curriculum 3rd ed. 2017. Chapter 29 Sarav M, Kovesdy C. Renal Disease., pg. 565-586

📄 Recent Major Changes 16 words ▾

Dosage and Administration, Preparation Instructions for Admixing Using a Parenteral Nutrition Container ( 2.3 ) 09/2020

📄 Package Label / Principal Display Panel ~1 min read ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label LOT EXP 2B6186 2000 mL NDC 0338-0499-06 20% ProSol - sulfite-free 20% (Amino Acid) Injection Pharmacy Bulk Package Not For Direct Infusion Rx Only EACH 100 mL CONTAINS ESSENTIAL AMINO ACIDS VALINE 1.44 g LYSINE (ADDED AS LYSINE ACETATE) 1.35 g HISTIDINE 1.18 g ISOLEUCINE 1.08 g LEUCINE 1.08 g PHENYLALANINE 1.00 g THREONINE 980 mg METHIONINE 760 mg TRYPTOPHAN 320 mg NONESSENTIAL AMINO ACIDS ALANINE 2.76 g GLYCINE 2.06 g ARGININE 1.96 g PROLINE 1.34 g GLUTAMIC ACID 1.02 g SERINE 1.02 g ASPARTIC ACID 600 mg TYROSINE 50 mg pH ADJUSTED WITH GLACIAL ACETIC ACID pH 6.0 (5.5 TO 6.5) mEq/L* ACETATE 140 *BALANCED BY IONS FROM AMINO ACIDS HYPERTONIC OSMOLARITY 1835 mOsmol/L (CALC) STERILE NONPYROGENIC CONTAINS NO MORE THAN 25 μg/L OF ALUMINUM ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN COMPOUNDING ADMIXTURES USE ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT STORE DOSAGE ADMIX FOR INTRAVENOUS ADMINISTRATION AS DIRECTED BY A PHYSICIAN SEE ACCOMPANYING DIRECTIONS FOR USE ONCE CONTAINER CLOSURE HAS BEEN PENETRATED WITHDRAWAL OF CONTENTS SHOULD BE COMPLETED WITHIN 4 HOURS AFFIX ACCOMPANYING LABEL FOR DATE AND TIME OF ENTRY STORE AT ROOM TEMPERATURE (25°C/77°F) CAUTION DO NOT USE UNLESS SOLUTION IS CLEAR AND SEAL IS INTACT A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND EFFICACY OF THE PRODUCT VIAFLEX CONTAINER PL 146 PLASTIC VIAFLEX CONTAINER PL 146 PLASTIC Baxter Logo BAXTER HEALTHCARE CORPORATION CLINTEC NUTRITION DIVISION DEERFIELD, IL 60015 USA MADE IN USA BAXTER, PROSOL, VIAFLEX AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC US PATENT NO 5 206 269 1800 1600 1400 1200 1000 800 600 400 ProSol Representative Container Label NDC 0338-0499-06

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
7K
Units reimbursed last 4 qtrs
24.1M
Gross reimbursed last 4 qtrs
$1.15M
Avg / prescription
$164.64
Avg / unit
$0.0478
Latest quarter Q1 2026
1.6KRx
Fee-for-service vs managed care ⓘ
62% FFS 38% MCO
Fee-for-service · 4,306 Rx Managed care · 2,681 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 30,525 units · 956 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 3,094 units · 96.5 per 100k residents IA Illinois: 341,533 units · 2,722 per 100k residents IL Indiana: 90 units · 1.3 per 100k residents IN Ohio: 15,987,507 units · 135,660 per 100k residents OH Pennsylvania: 55,136 units · 425 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 6,100 units · 87.1 per 100k residents MA California: 3,751,994 units · 9,629 per 100k residents CA Utah: 2,523,505 units · 73,851 per 100k residents UT Colorado: no data reported CO Nebraska: 80,375 units · 4,063 per 100k residents NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 79,145 units · 908 per 100k residents VA Maryland: 121,670 units · 1,969 per 100k residents MD Connecticut: 674,210 units · 18,640 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 297 units · 10.1 per 100k residents KS Arkansas: no data reported AR Tennessee: 14 units · 0.2 per 100k residents TN North Carolina: 101,850 units · 940 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 28,000 units · 691 per 100k residents OK Louisiana: 13 units · 0.3 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 107,416 units · 974 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 179,725 units · 795 per 100k residents FL
Units reimbursed · per 100k residents
0.2135,660
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Ohio 135,660 /100k
2 Utah 73,851 /100k
3 Connecticut 18,640 /100k
4 California 9,629 /100k
5 Nebraska 4,063 /100k
6 Illinois 2,722 /100k
7 Maryland 1,969 /100k
8 Georgia 974 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Prosol — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Prosol. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$4.19M
Claims incl. refills
24.8K
Beneficiaries
2.7K
Spend / beneficiary
$1,572.09
Spend / claim
$168.79
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
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
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Baxter Healthcare Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Baxter Healthcare Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00338-0433-04 · Baxter 00338-0502-03 · Baxter →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.