Plenamine LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE 1.18 g/100mL; 1.04 g/100mL; 1.04 g/100mL; 960 mg/100mL; 749 mg/100mL; 749 mg/100mL; 749 mg/100mL; 250 mg/100mL; 2.17 g/100mL; 1.47 g/100mL; 1.0 Solution — NDC 0264-4500-00 (Billing 00264-4500-00)
This is a package of Plenamine LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE 1.18 g/100mL; 1.04 g/100mL; 1.04 g/100mL; 960 mg/100mL; 749 mg/100mL; 749 mg/100mL; 749 mg/100mL; 250 mg/100mL; 2.17 g/100mL; 1.47 g/100mL; 1.0 Solution from B. Braun Medical Inc., marketed since Sep 2018 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 0264-4500-00 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0264 labeler · 4500 product · 00 package
- Package marketed since
- Sep 28, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 0264450000 8
- Medicaid fills, this package
- 2,929 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 1, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 079645
- GCN: 46184
- GPI-14 (Medi-Span): 80302010102060
- HICL (First Databank): 045683
- AHFS class code: 40:20.00.00
- RxCUI (RxNorm): 800584
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.3047 | $2,437.60 / 8000 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.0494 | $395.20 / 8000 ml |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00264-4500-00 You're viewing this | 8 CONTAINER in 1 CASE / 1000 mL in 1 CONTAINER | 2018-09-28 | — | Active |
| 00264-4500-05 0264-4500-05 Main listing | 4 CONTAINER in 1 CASE / 2000 mL in 1 CONTAINER | 2019-10-29 | — | Active |
This pack accounts for about 43% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Plenamine LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE 1.18 g/100mL; 1.04 g/100mL; 1.04 g/100mL; 960 mg/100mL; 749 mg/100mL; 749 mg/100mL; 749 mg/100mL; 250 mg/100mL; 2.17 g/100mL; 1.47 g/100mL; 1.0 Solution?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Plenamine 1.18 g/100mL; 1.04 g/100mL; 1.04 g/100mL; 960 mg/100mL; 749 mg/100mL; 749 mg/100mL; 749 mg/100mL; 250 mg/100mL; 2.17 g/100mL; 1.47 g/100mL; 1.0this 00264-4500-00 | B. | 1000 ml | — | — | FDA listed | — |
| Clinisol 1.18 g/100mL; 1.04 g/100mL; 1.04 g/100mL; 960 mg/100mL; 894 mg/100mL; 749 mg/100mL; 749 mg/100mL; 749 mg/100mL; 250 mg/100mL; 2.17 g/100mL; 1 00338-0502-03 | Baxter | 500 ml | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
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?
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from B. Braun Medical Inc. labeler code 00264
- Acetaminophen 10 mg/mL Injection NDC 0264-4100-90
- Magnesium Sulfate in Water magnesium sulfate heptahydrate 2 g/50mL Injection, Solution NDC 0264-4204-52
- Magnesium Sulfate in Water magnesium sulfate heptahydrate 4 g/50mL Injection, Solution NDC 0264-4205-52
- Magnesium Sulfate in Water magnesium sulfate heptahydrate 4 g/100mL Injection, Solution NDC 0264-4206-54
- Magnesium Sulfate in Dextrose magnesium sulfate heptahydrate 10 mg/mL Injection, Solution NDC 0264-4400-54
- NutriLipid I.V. Fat Emulsion Soybean Oil 20 g/100mL Injection, Solution NDC 0264-4460-00
- Levetiracetam 5 mg/mL Injection NDC 0264-5009-90
- METRONIDAZOLE 500 mg/100mL Solution NDC 0264-5535-32
- Calcium Gluconate 98 mg/mL Injection, Solution NDC 0264-5600-52
- Rocuronium Bromide 50 mg/5mL Injection NDC 0264-5711-10
- Sodium Chloride .9 g/100mL Injection, Solution NDC 0264-5802-00
- Sodium Chloride .45 g/100mL Injection, Solution NDC 0264-5804-00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Plenamine™ 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. This use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when: — Gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy; — Bowel rest is needed because of gastrointestinal surgery or its complications such as ileus, fistulae or anastomotic leaks; — Tube feeding methods alone cannot provide adequate nutrition.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The appropriate daily dose of amino acids to be used with dextrose or with dextrose and intravenous fat emulsion will depend upon the metabolic status and clinical response of the patient as therapy proceeds. Doses which achieve nitrogen equilibrium or positive balance are the most desirable. The dosage on the first day should be approximately half the anticipated optimal dosage and should be increased gradually to minimize glycosuria; similarly, withdrawal should be accomplished gradually to avoid rebound hypoglycemia.
Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat free TPN. The amount administered is dosed on the basis of amino acids/kg of body weight/day.
In general, two to three g/kg of body weight for neonates and infants with adequate calories are sufficient to satisfy protein needs and promote positive nitrogen balance. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L). DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE Plenamine™ 15% in a Pharmacy Bulk Package is not intended for direct infusion.
The container closure may be penetrated only once using a suitable unvented sterile transfer device or dispensing set which allows measured dispensing of the contents. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Once the closure is penetrated, the contents should be dispensed as soon as possible; the transfer of contents must be completed within 4 hours of closure entry.
The bag may be stored at room temperature (25°C) after the closure has been entered. When using Plenamine™ 15% in patients with a need for fluid volume restriction, it can be diluted as follows: Volume Amount Final Concentration Plenamine™ 15% 500 mL 75 g 7.5% Dextrose 70% 250 mL 175 g 17.5% Intralipid® 20% 250 mL 50 g 5.0% This will provide 1395 kilocalories (kcal) per 1000 mL of admixture with a ratio of 118 non-protein calories per gram of nitrogen and an osmolarity of 1559 mOsmol/L. In patients where the need for fluid restriction is not so marked, either of the following regimens may be used dependent upon the energy needs of the patient.
Volume Amount Final Concentration Plenamine™ 15% 500 mL 75 g 3.75% Dextrose 50% 1000 mL 500 g 25% Intralipid® 20% 500 mL 100 g 5% This will provide 1500 kcal per 1000 mL of admixture with a ratio of 228 non-protein calories per gram of nitrogen and an osmolarity of 1631 mOsmol/L. Volume Amount Final Concentration Plenamine™ 15% 500 mL 75 g 3.75% Dextrose 30% 1000 mL 300 g 15% Intralipid® 10% 500 mL 50 g 2.5% This will provide 935 kcal per 1000 mL of admixture with a ratio of 158 non-protein calories per gram of nitrogen and an osmolarity of 1126 mOsmol/L.
A. Total Parenteral Nutrition (Central Infusion) In unstressed adult patients with no unusual nitrogen losses, a minimum dosage of 0.1 gram nitrogen (4.2 mL of Plenamine™ 15%) plus 4.4 grams (15 calories) of dextrose per kilogram of body weight per day are required to achieve nitrogen balance and weight stability. Intravenous fat emulsion may be used as a partial substitute for dextrose.
This regimen provides a ratio of 150 non-protein calories per gram of nitrogen. For patients stressed by surgery, trauma or sepsis, and those with unusual nitrogen losses, the dosage required for maintenance may be as high as 0.3 to 0.4 grams of nitrogen (13 to 17 mL Plenamine™ 15%) per kilogram of body weight per day, with proportionate increases in non-protein calories. Periodic assessment of nitrogen balance of the individual patient is the best indicator of proper dosage.
Volume overload and glycosuria may be encountered at high dosage, and nitrogen balance may not be achieved in extremely hype… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS This solution should not be used in patients in hepatic coma, severe renal failure, metabolic disorders involving impaired nitrogen utilization or hypersensitivity to one or more amino acids.
⚠️ Warnings ▾
WARNINGS Administration of amino acids solutions at excessive rates or to patients with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. Conservative doses of amino acids should be given to these patients, dictated by the nutritional status of the patient. Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient's clinical status re-evaluated.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS (See WARNINGS , PRECAUTIONS and Special Precautions for Central Infusion .)
🤰 Pregnancy ▾
D. Pregnancy Category C Animal reproduction studies have not been conducted with Plenamine™ 15%. It is also not known whether Plenamine™ 15% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Plenamine™ 15% should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
F. Pediatric Use Safety and effectiveness of Plenamine™ 15% Amino Acids Injection in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acids injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature.
H. Admixtures Admixtures should be prepared under a laminar flow hood using aseptic technique. Admixtures should be stored under refrigeration and must be administered within 24 hours after removal from refrigerator. Filters of less than 1.2 micron pore size must not be used with admixtures containing lipid emulsion.
🆘 Overdosage ▾
OVERDOSAGE In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS and PRECAUTIONS .)
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Plenamine™ 15% Amino Acids Injection provides seventeen crystalline amino acids. This completely utilizable substrate promotes protein synthesis and wound healing and reduces the rate of protein catabolism. A.
Total Parenteral Nutrition (Central Infusion) When enteral feeding is inadvisable, Plenamine™ 15% given by central venous infusion in combination with energy sources, vitamins, trace elements and electrolytes, will completely satisfy the requirements for weight maintenance or weight gain, depending upon the dose selected. The energy component in parenteral nutrition by central infusion may be derived solely from dextrose or may be provided by a combination of dextrose and intravenous fat emulsion. The addition of intravenous fat emulsion provides essential fatty acids and permits a dietary balance of fat and carbohydrate, at the same time offering the option of reducing the dextrose load and/or increasing the total caloric input.
An adequate energy supply is essential for optimal utilization of amino acids. B. Total Parenteral Nutrition (Peripheral Infusion) Plenamine™ 15% can also be administered as part of a total parenteral nutrition program by peripheral vein when the enteral route is inadvisable and use of the central venous catheter is contraindicated.
Reduction of protein loss can be achieved by use of diluted Plenamine™ 15% in combination with dextrose or with dextrose and intravenous fat emulsion by peripheral infusion. Complete peripheral intravenous nutrition can be achieved in patients with low caloric requirements by a Plenamine™ 15% dextrose-fat regimen.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Plenamine™ 15% Amino Acids Injection is supplied sterile and nonpyrogenic in flexible plastic bags, Pharmacy Bulk Packages, 1000 mL packaged 8 per case and 2000 mL packaged 4 per case. NDC REF Size 0264-4500-05 S4505 2000 mL 0264-4500-00 S4500 1000 mL Not made with natural rubber latex, DEHP or PVC. Storage Store in the closed corrugated case; do not expose solution to light until ready for use.
Do not remove container from overwrap until ready to use. Do not use if overwrap has been opened or damaged. Exposure of pharmaceutical products to heat should be minimized.
Avoid excessive heat. It is recommended that the product be stored at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Brief exposure to temperatures above 25°C during transport and storage will not adversely affect the product. Solution that has been frozen must not be used.
📦 Storage and Handling ▾
Storage Store in the closed corrugated case; do not expose solution to light until ready for use. Do not remove container from overwrap until ready to use. Do not use if overwrap has been opened or damaged.
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Brief exposure to temperatures above 25°C during transport and storage will not adversely affect the product.
Solution that has been frozen must not be used.
📋 Description ▾
DESCRIPTION Plenamine™ 15% Amino Acids Injection in a Pharmacy Bulk Package is a sterile, clear, nonpyrogenic solution of essential and nonessential amino acids for intravenous infusion in parenteral nutrition following appropriate dilution. Plenamine™ 15% in a Pharmacy Bulk Package is not for direct infusion. It is a sterile dosage form which contains several single doses for use in a pharmacy admixture program in the preparation of intravenous parenteral fluids.
Each 100 mL contains: Essential Amino Acids Lysine (from Lysine Acetate, USP) 1.18 g Leucine, USP 1.04 g Phenylalanine, USP 1.04 g Valine, USP 960 mg Isoleucine, USP 749 mg Methionine, USP 749 mg Threonine, USP 749 mg Tryptophan, USP 250 mg Nonessential Amino Acids Alanine, USP 2.17 g Arginine, USP 1.47 g Glycine, USP 1.04 g Histidine, USP 894 mg Proline, USP 894 mg Glutamic Acid 749 mg Serine, USP 592 mg Aspartic Acid, USP 434 mg Tyrosine, USP 39 mg Water for Injection, USP qs Essential Amino Acids 6.7 g Nonessential Amino Acids 8.3 g Total Amino Acids 15.0 g Total Nitrogen 2.37 g Acetate Acetate from Lysine Acetate, USP and acetic acid used for pH adjustment.
147.4 mEq/L Osmolarity (calculated) 1378 mOsmol/L pH 5.6 (5.2–6.0) The formulas for the individual amino acids are as follows: Essential Amino Acids Lysine Acetate H 2 N(CH 2 ) 4 CH(NH 2 )COOH•CH 3 COOH Leucine (CH 3 ) 2 CHCH 2 CH(NH 2 )COOH Phenylalanine Valine (CH 3 ) 2 CHCH(NH 2 )COOH Isoleucine CH 3 CH 2 CH(CH 3 )CH(NH 2 )COOH Methionine CH 3 S(CH 2 ) 2 CH(NH 2 )COOH Threonine CH 3 CH(OH)CH(NH 2 )COOH Tryptophan 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 Histidine Proline Glutamic Acid HOOC(CH 2 ) 2 CH(NH 2 )COOH Serine HOCH 2 CH(NH 2 )COOH Aspartic Acid HOOCCH 2 CH(NH 2 )COOH Tyrosine Chemical Structure Chemical Structure Chemical Structure Chemical Structure Chemical Structure
⚠️ Precautions ▾
PRECAUTIONS A. General It is essential to provide adequate calories concurrently if parenterally administered amino acids are to be retained by the body and utilized for protein synthesis. The administration of Plenamine™ 15% Amino Acids Injection as part of total parenteral nutrition (TPN) with large volumes of hyperosmotic fluids requires periodic monitoring of the patient for signs of hyperosmolarity, hyperglycemia, glycosuria and hypertriglyceridemia.
During parenteral nutrition with concentrated dextrose and amino acids solutions, essential fatty acid deficiency syndrome may develop but may not be clinically apparent. Early demonstration of this condition can only be accomplished by gas liquid chromatographic analysis of plasma lipids. The syndrome may be prevented or corrected by appropriate treatment with intravenous fat emulsions.
For complete nutritional support, TPN regimens must also include multiple vitamins and trace elements. Potentially incompatible ions such as calcium and phosphate may be added to alternate infusate bottles to avoid precipitation. Although the metabolizable acetate ion in Plenamine™ 15% diminishes the risk of acidosis, the physician must be alert to the potential appearance of this disorder.
Initiation and termination of infusions of TPN fluids must be gradual to permit adjustment of endogenous insulin release. Undiluted Plenamine™ 15% should not be administered peripherally. When administered centrally, it should be diluted with appropriate diluents, e.g., dextrose, electrolytes and other nutrient components, to at least half strength.
(See DOSAGE AND ADMINISTRATION . ) Caution against volume overload should be exercised. Drug product contains no more than 25 mcg/L of aluminum. B.
Laboratory Tests Infusion of Plenamine™ 15% without concomitant infusion of an adequate number of non-protein calories may result in elevated BUN. Monitoring of BUN is required and the balance between Plenamine™ 15% and the calorie source may require adjustment. Frequent clinical evaluations and laboratory determinations are required to prevent the complications which may occur during the administration of solutions used in TPN.
Laboratory tests should include blood glucose, serum electrolytes, liver and kidney function, serum osmolarity, blood ammonia, serum protein, pH, hematocrit, WBC and urinary glucose. When Plenamine™ 15% is combined with electrolytes, care should be used in administering this solution to patients with congestive heart failure, renal failure, edema, adrenal hyperactivity, acid-base imbalance and those receiving diuretics or antihypertensive therapy. Total volume infused should be closely monitored.
Serum electrolytes should be monitored daily in these patients. C. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with Plenamine™ 15% have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
D. Pregnancy Category C Animal reproduction studies have not been conducted with Plenamine™ 15%. It is also not known whether Plenamine™ 15% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Plenamine™ 15% should be given to a pregnant woman only if clearly needed. E. Nursing Mothers Caution should be exercised when Plenamine™ 15% is administered to a nursing woman.
F. Pediatric Use Safety and effectiveness of Plenamine™ 15% Amino Acids Injection in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acids injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature.
G. Special Precautions for Central Infusion TPN delivered by indwelling catheter through a central or large peripheral vein is a special technique requiring a team effort by physician, nurse and pharmacist. The responsibility for administering this therapy should be confined… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
E. Nursing Mothers Caution should be exercised when Plenamine™ 15% is administered to a nursing woman.
G. Special Precautions for Central Infusion TPN delivered by indwelling catheter through a central or large peripheral vein is a special technique requiring a team effort by physician, nurse and pharmacist. The responsibility for administering this therapy should be confined to those trained in the procedures and alert to signs of complications.
Complications known to occur from the placement of central venous catheter are pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis, and air/catheter emboli. The risk of sepsis is present during intravenous therapy, especially when using central venous catheters for prolonged periods. It is imperative that the preparation of admixtures and the placement and care of the catheters be accomplished under controlled aseptic conditions.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
C. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with Plenamine™ 15% have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
📖 Instructions for Use ▾
Preparation Instructions for Plenamine™ 15% Bags for Direct Infusion Caution: Plenamine™ 15% Pharmacy Bulk Package is not intended for direct intravenous administration. The pharmacy bulk package is for use in a Pharmacy Admixture Service only. Use of this product is restricted to a suitable work area, such as a laminar flow hood (or an equivalent clean air compounding area).
Additives should not be made to Pharmacy Bulk Packages. Designed for use with an unvented sterile dispensing set. Step 1: Inspect Pharmacy Bulk Package overwrap and primary bag and do not use if damaged.
Inspect oxygen indicator and do not use if oxygen indicator is pink or dark pink. Use only if container and seals are intact. Step 2: To open, tear overwrap starting from the tear notches (Figure 1).
Remove Plenamine™ 15% Pharmacy Bulk Package bag from overwrap and discard oxygen indicator, oxygen absorber and overwrap. Step 3: Inspect Plenamine™ 15% Pharmacy Bulk Package bag visually (Figure 2). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Inspect Plenamine™ 15% for cloudiness, haze or particulate matter in good lighting. Discard the bag if any particulates or discoloration are observed. Step 4: Remove aluminum foil of outlet port at the bottom of the Pharmacy Bulk Package bag (Figure 3a) and attach an unvented sterile dispensing set (Figure 3b).
The container closure may be penetrated only one time, utilizing a suitable sterile dispensing set which allows measured dispensing of the contents. The withdrawal of container contents should be accomplished without delay using aseptic technique. Discard container no later than 4 hours after initial closure puncture.
Use of a syringe with needle is not recommended. Multiple entries increase the potential of the microbial and particulate contamination. Step 1 Illustration Step 2 Figure 1 Illustration Step 3 Figure 2 Illustration Step 4 Figure 3 Illustration
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label 0857/12624147/1124 NDC 0264-4500-00 REF S4500 LOT EXP: INT: Plenamine ™ 15% Amino Acids Injection 1000 mL PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION Protect from light until use. For Intravenous Use Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Solution that has been frozen must not be used. Do not expose to light before using.
Once closure is penetrated, transfer contents promptly, total time not to exceed 4 hours. See package insert for proper use of Pharmacy Bulk Package. Affix accompanying label for date and time of entry Each 100 mL contains: Essential Amino Acids Lysine (from Lysine Acetate, USP) 1.18 g Leucine, USP 1.04 g Phenylalanine, USP 1.04 g Valine, USP 960 mg Isoleucine, USP 749 mg Methionine, USP 749 mg Threonine, USP 749 mg Tryptophan, USP 250 mg Nonessential Amino Acids Alanine, USP 2.17 g Arginine, USP 1.47 g Glycine, USP 1.04 g Histidine, USP 894 mg Proline, USP 894 mg Glutamic Acid 749 mg Serine, USP 592 mg Aspartic Acid, USP 434 mg Tyrosine, USP 39 mg Water for Injection USP qs pH 5.6 (5.2-6.0), adjusted with acetic acid.
Acetate: 147.4 mEq/L, including quantity used for pH adjustment. Calculated Osmolarity: 1378 mOsmol/L Contains no more than 25 mcg/L of aluminum. Sterile, nonpyrogenic.
Single dose container. Use only if bag and seal are undamaged and solution is clear. Do not remove container from overwrap until ready for use.
Do not use if overwrap has been opened or damaged. Administer intravenously. Not made with natural rubber latex, DEHP or PVC.
Rx only B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Made in Germany LD-558-2 SET Recycle Symbol 7 OTHER S4500 Container Label
PRINCIPAL DISPLAY PANEL - Accompanying 1000 mL and 2000 mL Bag Label Date of Entry:___/____/_____ Time of Entry:____________________AM/PM Discard______hours after initial entry LD-585-2 0/12625337/1221 Accompanying Entry label for 1000 and 2000 containers
PRINCIPAL DISPLAY PANEL - 2000 mL Bag Label 0857/12627286/1124 REF S4505 NDC 0264-4500-05 LOT EXP: INT: Plenamine ™ 15% Amino Acids Injection 2000 mL PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION Protect from light until use. For Intravenous Use Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Solution that has been frozen must not be used. Do not expose to light before using.
Once closure is penetrated, transfer contents promptly, total time not to exceed 4 hours. See package insert for proper use of Pharmacy Bulk Package. Affix accompanying label for date and time of entry Each 100 mL contains: Essential Amino Acids Lysine (from Lysine Acetate, USP) 1.18 g Leucine, USP 1.04 g Phenylalanine, USP 1.04 g Valine, USP 960 mg Isoleucine, USP 749 mg Methionine, USP 749 mg Threonine, USP 749 mg Tryptophan, USP 250 mg Nonessential AminoAcids Alanine, USP 2.17 g Arginine, USP 1.47 g Glycine, USP 1.04 g Histidine, USP 894 mg Proline, USP 894 mg Glutamic Acid 749 mg Serine, USP 592 mg Aspartic Acid, USP 434 mg Tyrosine, USP 39 mg Water for Injection USP qs pH 5.6 (5.2-6.0), adjusted with acetic acid.
Acetate: 147.4 mEq/L, including quantity used for pH adjustment. Calculated Osmolarity: 1378 mOsmol/L Contains no more than 25 mcg/L of aluminum. Sterile, nonpyrogenic.
Single dose container. Use only if bag and seal are undamaged and solution is clear. Do not remove container from overwrap until ready to use.
Do not use if overwrap has been opened or damaged. Administer intravenously. Not made with natural rubber latex, DEHP or PVC.
Rx only B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Made in Germany LD-633-2 SET Recycle Symbol 7 OTHER S4505 Container Label
Medicaid utilization & spend
Medicaid utilization by pack size
Medicare Part D spend CMS · PART D · 2026 (Q1)
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |