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Travasol Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine 730 mg/100mL; 560 mg/100mL; 580 mg/100mL; 400 mg/100mL; 600 mg/100mL; 580 mg/100mL; 480 mg/100mL; 420 mg/100mL; 180 mg/100mL; 2.07 g/100mL Injection, 500 mL — NDC 00338-0644-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Travasol Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine 730 mg/100mL; 560 mg/100mL; 580 mg/100mL; 400 mg/100mL; 600 mg/100mL; 580 mg/100mL; 480 mg/100mL; 420 mg/100mL; 180 mg/100mL; 2.07 g/100mL Injection, 500 mL — NDC 0338-0644-03 (Billing 00338-0644-03)

by Baxter Healthcare Corporation · 500 mL in 1 BAG

This is a package of 500 mL of Travasol Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine 730 mg/100mL; 560 mg/100mL; 580 mg/100mL; 400 mg/100mL; 600 mg/100mL; 580 mg/100mL; 480 mg/100mL; 420 mg/100mL; 180 mg/100mL; 2.07 g/100mL Injection from Baxter Healthcare Corporation, marketed since Aug 1984 and currently FDA-listed.

NDC 00338-0644-03
🏷️ FDA NDC (as labeled) 0338-0644-03 billing pads the labeler segment with a zero
This package
Contains500 mL Medicaid pays$0.0743 / unit · 12 mo Per package$0.07 / 1 bag · Medicaid Pack sizes3 compare ↓
Also priced by: Part D plans $0.0299/unit — full pricing hub ↓
Product page 00338-0644-06 Also comes in: 1000 ml 0338-0644-04 2000 ml 0338-0644-06
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
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0338-0644-03 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0338 labeler · 0644 product · 03 package
Package marketed since
Aug 23, 1984
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
500 mL per package
Barcode (UPC-A, from the NDC)
3 0338064403 2
Medicaid fills, this package
14 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 (Shortage of an inactive ingredient component). Unavailable Shortage details →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0338-0644-03
Product NDC 0338-0644
11-digit billing NDC 00338064403
NCPDP billing unit ML — per mL (volume)
RxCUI 801644, 801648
UNII GMW67QNF9C, 47E5O17Y3R, JNJ23Q2COM, AE28F7PNPL, 04Y7590D77, HG18B9YRS7 +9 more
Application # NDA018931
SPL Set ID 8543b5be-0f43-4891-9e56-d7c39fe839b5
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 1984-08-23
Route INTRAVENOUS
Dosage form INJECTION
Substance LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE

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

GPI-14 80302010102040
GPI class Travasol
GCN Seq No 063536
GCN 99258
HICL code 035295
Ingredient (HICL) Parenteral Amino Acid 10% No.6
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 TRAVASOL 10% SOLN VIAFLEX
FDB brand name Travasol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 063536
  • GCN: 99258
  • GPI-14 (Medi-Span): 80302010102040
  • HICL (First Databank): 035295
  • AHFS class code: 40:20.00.00
  • RxCUI (RxNorm): 801644
Why two NDCs? The FDA registers this code as 0338-0644-03 — 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 → 00338-0644-03. 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 TRAVASOL 10% SOLN VIAFLEX Ingredient Parenteral Amino Acid 10% No.6

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.0743 $0.07 / 1 bag
Medicare drug plans payPart D · Q2 2026 $0.0299 $0.03 / 1 bag
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
00338-0644-03 You're viewing this 500 mL in 1 BAG 1984-08-23 — Active
00338-0644-04 0338-0644-04 1000 mL in 1 BAG 1984-08-23 — Active
00338-0644-06 0338-0644-06 Main listing 2000 mL in 1 BAG 1984-08-23 — Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 500 mL — 500 ml in 1 bag.
How does this package differ from NDC 00338-0644-04?
Both are Travasol Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine 730 mg/100mL; 560 mg/100mL; 580 mg/100mL; 400 mg/100mL; 600 mg/100mL; 580 mg/100mL; 480 mg/100mL; 420 mg/100mL; 180 mg/100mL; 2.07 g/100mL Injection — the drug itself is identical. This page's package is the 500 mL one, while NDC 00338-0644-04 is the 1000 ml package.
What NDC number is used to bill for this package of Travasol Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine 730 mg/100mL; 560 mg/100mL; 580 mg/100mL; 400 mg/100mL; 600 mg/100mL; 580 mg/100mL; 480 mg/100mL; 420 mg/100mL; 180 mg/100mL; 2.07 g/100mL Injection?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Travasol 730 mg/100mL; 560 mg/100mL; 580 mg/100mL; 400 mg/100mL; 600 mg/100mL; 580 mg/100mL; 480 mg/100mL; 420 mg/100mL; 180 mg/100mL; 2.07 g/100mLthis 00338-0644-03 Baxter 500 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

🏛️
1984
On the market since
Aug 1984
📍
2026
Currently FDA-listed
42 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 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.

2 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 CORP
FDA applicationNDA018931 (NDA)
Labeler code00338
First marketedAug 1984
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 77 words ▾

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

TRAVASOL may be used to treat negative nitrogen balance in patients. (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 TRAVASOL is supplied as a pharmacy bulk package for admixing only and is not for direct intravenous infusion . Prior to administration, TRAVASOL 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 TRAVASOL 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.

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. • TRAVASOL is intended for use in the preparation of sterile, intravenous admixtures.

Because additives may be incompatible with TRAVASOL, evaluate all additions for compatibility.

2.2Administration Instructions TRAVASOL is for admixing use only. It is not for direct intravenous infusion. Prior to administration, TRAVASOL must be diluted with other compatible intravenous fluids or used as an admixture with or without dextrose, electrolytes and/or lipid emulsion. • TRAVASOL 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. • TRAVASOL is for admixing with dextrose injection and/or lipid emulsions using a parenteral nutrition container. • When TRAVASOL 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 TRAVASOL-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 to administration, do not pressurize the flexible container to increase flow rates, and… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 189 words ▾

3 DOSAGE FORMS AND STRENGTHS TRAVASOL 10% is a sterile solution of 10 grams of amino acids per 100 mL (0.1 gram/mL) available in 500 mL, 1000 mL, and 2000 mL flexible containers, which contain essential and nonessential amino acids. Table 3 describes the individual components of TRAVASOL. Table 3.

Ingredients per 100 mL of TRAVASOL Amino Acids 10 g Total Nitrogen 1.65 g Essential Amino Acids Leucine 730 mg Isoleucine 600 mg Lysine (added as the hydrochloride salt) 580 mg Valine 580 mg Phenylalanine 560 mg Histidine 480 mg Threonine 420 mg Methionine 400 mg Tryptophan 180 mg Nonessential Amino Acids Alanine 2.07 g Arginine 1.15 g Glycine 1.03 g Proline 680 mg Serine 500 mg Tyrosine 40 mg Anion profiles per liter Balanced by ions from amino acids. Acetate Derived from pH adjustment with glacial acetic acid. 88 mEq Chloride Contributed by the Lysine Hydrochloride.

40 mEq pH (Range); pH adjusted with glacial acetic acid 6.0 (5.0 to 7.0) Osmolarity (calc) 998 mOsm/L Injection: 10% (0.1 grams/mL), 10 grams of amino acid solution per 100 mL in 500 mL, 1000 mL, and 2000 mL flexible containers. (3)

⛔ Contraindications 87 words ▾

4 CONTRAINDICATIONS The use of TRAVASOL 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 mOsm/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, including TRAVASOL. In some cases, fatal outcomes due to pulmonary embolism have occurred. TRAVASOL 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 TRAVASOL. 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 Syn… [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 TRAVASOL.

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 TRAVASOL 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 TRAVASOL.

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 TRAVASOL in human milk, the effects of TRAVASOL 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 TRAVASOL to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TRAVASOL and any potential adverse effects on the breastfed child from TRAVASOL 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 TRAVASOL 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 TRAVASOL 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 TRAVASOL 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), Warnings and Precautions (5.10) ].

8.7Hepatic Impairme… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 165 words ▾

8.1Pregnancy Risk Summary Limited published data with injectable amino acids solutions, including TRAVASOL 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 TRAVASOL.

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 166 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 TRAVASOL 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 TRAVASOL 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 86 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 TRAVASOL 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 TRAVASOL 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 TRAVASOL 10% (amino acids) injection is available in plastic Pharmacy Bulk Package flexible containers in the following sizes as shown in Table 5 below. Table 5. TRAVASOL Dosage Forms Code Volume NDC Number 1B6623 500 mL NDC 0338-0644-03 1B6624 1000 mL NDC 0338-0644-04 1B6626P 2000 mL NDC 0338-0644-06 Minimize exposure of TRAVASOL to heat and avoid excessive heat.

Protect from freezing. Store TRAVASOL at room temperature (25ºC/77ºF). 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 TRAVASOL 10% (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) ] .

TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL 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 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 TRAVASOL 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 TRAVASOL: • 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 2nd ed. 2012. Chapter 29 Wolk R, Foulks C. Renal Disease., pg. 500

📄 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 Container Label 1B6624 1000 mL NDC 0338-0644-04 10% TRAVASOL 10% (Amino Acid) Injection Pharmacy Bulk Package Not For Direct Infusion Rx Only EACH 100mL CONTAINS ESSENTIAL AMINO ACIDS LEUCINE 730 mg ISOLEUCINE 600 mg LYSINE(ADDED AS THE HYDROCHLORIDE SALT) 580 mg VALINE 580 mg PHENYLALANINE 560 mg HISTIDINE 480 mg THREONINE 420 mg METHIONINE 400 mg TRYPTOPHAN 180 mg NONESSENTIALAMINO ACIDS ALANINE 2.07 g ARGININE 1.15 g GLYCINE 1.03 g PROLINE 680 mg SERINE 500 mg TYROSINE 40 mg pH ADJUSTED WITH GLACIAL ACETIC ACID pH 6.0 (5.0 TO 7.0) mEq/L* ACETATE - 88 CHLORIDE - 40 *BALANCED BY IONS FROM AMINO ACIDS HYPERTONIC OSMOLARITY 998 mOsmo/L (CALC) STERILE NONPYROGENIC CONTAINS NO MORE THAN 25 µg/L OF ALUMINUM ADDITIVES MAY BE INCOMPATIBLE WITH THE FLUID WITHDRAWN FROM THIS CONTAINER 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 SHOULDBE COMPLETED WITHOUT DELAY AFFIX ACCOMPANYING LABEL FOR DATE AND TIME OF ENTRY DISPENSE CONTENTS WITHIN 4 HOURS AFTER INITIAL ENTRY 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 Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN BELGIUM PL 146 PLASTIC BAXTER TRAVASOL AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC EXP YYYY-MM BE-35-04-035 1 2 3 4 5 6 7 8 9 Carton Label Carton Label Lot: xx Qty: 24-500mL Exp: x x Code: 1B6623 NDC: 0338-0644-03 10% Travasol (Amino Acid) INJ Viaflex Container (17) XX00 (10) xx (01) 50303380644037 07/31/09 10:24:28 07-35-C Representative Container Label 0338-0644-04 RepresentativeTravasol Carton Label 0338-0644-03

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.
📅 Q4 2025 – Q1 2026 · 2 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
14
Units reimbursed last 4 qtrs
50.1K
Gross reimbursed last 4 qtrs
$3.7K
Avg / prescription
$265.63
Avg / unit
$0.0743
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 14 Rx Managed care · 0 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: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 50,055 units · 128 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
128128
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 California 128 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
2000 ml00338-0644-06 12,722 Rx · $3,693,443
1000 ml00338-0644-04 333 Rx · $125,666
500 ml this page00338-0644-03 14 Rx · $3,719
Drug total (last 4 qtrs): 13,069 Rx · 39,060,540 units · $3,822,828 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Travasol — 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 Travasol. 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
$9.8K
Claims incl. refills
38
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$259.09
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1000 ml (00338-0644-04), 2000 ml (00338-0644-06). Each has its own NDC and its own page — see the package list near the top of this page.
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.
← 00338-0603-03 · Baxter 00338-0656-04 · 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.