CUPRIC CHLORIDE .4 mg/mL Injection, Solution — NDC 80830-2301-5 (Billing 80830-2301-05)
This is a package of CUPRIC CHLORIDE .4 mg/mL Injection, Solution from Amneal Pharmaceuticals Private Limited, marketed since Jan 2026 and currently FDA-listed. It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 204536
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 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 1, 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 | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 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 |
|---|---|---|---|---|
| 80830-2301-05 You're viewing this Main listing | 25 VIAL in 1 CARTON / 10 mL in 1 VIAL | 2026-01-29 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Copper .4 mg/mL 00409-4092-01 | Hospira, | 25 vials | — | AP | FDA listed | — |
| Cupric Chloride .4 mg/mL 51754-0103-03 | Exela | 10 vials | — | AP | FDA listed | — |
| Cupric Chloride .4 mg/mL 70069-0506-25 | Somerset | 25 vials | — | AP | FDA listed | — |
| Cupric Chloride .4 mg/mL 72603-0351-25 | Northstar | 25 vials | — | AP | FDA listed | — |
| Cupric Chloride .4 mg/mL 72819-0234-99 | Archis | 25 vials | — | AP | FDA listed | — |
| Cupric Chloride .4 mg/mLthis 80830-2301-05 | Amneal | 25 vials | — | — | FDA listed | — |
| Cupric Chloride .4 mg/mL 84897-0013-25 | Renova | 25 vials | — | AP | 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.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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9 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 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 1, 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
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 Cupric chloride injection is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain copper serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Cupric chloride injection contains 0.4 mg of copper/mL and is administered intravenously only after dilution. The additive should be diluted in a volume of fluid not less than 100 mL. For the adult receiving TPN, the suggested additive dosage of copper is 0.3 mg/day to 0.5 mg/day.
For pediatric patients, the suggested additive dosage of copper is 20 mcg/kg/day (0.05 mL/kg/day) up to a maximum of 500 mcg/day. This product is not appropriate for patients weighing less than 4 kg due to the inability to measure the appropriate amount of the product. Do not administer cupric chloride injection intramuscularly because the acidic pH of the solution may cause considerable tissue irritation.
Cupric chloride injection should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. The solution contains no preservatives; discard the unused portion immediately after the admixture procedure is completed. Cupric chloride injection should be inspected visually for particulate matter and discoloration prior to administration.
Do not use unless the solution is clear and the seal is intact. Cupric ion may degrade ascorbic acid in TPN solutions. In order to avoid this loss of ascorbate, multivitamin additives should be added to TPN solutions immediately prior to infusion.
Alternatively, the multivitamin additive may be added to one container of TPN solution, followed by copper in a subsequent container.
⛔ Contraindications ▾
CONTRAINDICATIONS Cupric chloride injection is contraindicated in patients with hypersensitivity to copper (see WARNINGS: Hypersensitivity Reactions ).
⚠️ Warnings ▾
WARNINGS Hepatic Accumulation Copper is primarily eliminated in the bile and excretion is decreased in patients with cholestasis and/or cirrhosis. Hepatic accumulation of copper has been reported in autopsies of patients receiving long-term parenteral nutrition containing copper at dosages higher than recommended. Administration of copper to patients with cholestasis and/or cirrhosis may cause hepatic accumulation of copper.
Administration of copper to patients with Wilson disease, an inborn error of copper metabolism with a defect in hepatocellular copper transport, may cause both increased hepatic accumulation of copper and aggravation of the underlying hepatocellular degeneration. For patients with cholestasis, biliary dysfunction, or cirrhosis, monitor hepatic and biliary function during long-term administration of cupric chloride injection. If a patient develops signs or symptoms of hepatobiliary disease during the use of cupric chloride injection, obtain serum concentrations of copper and ceruloplasmin and adjust the dose as indicated (see PRECAUTIONS: Hepatic Impairment ).
Hypersensitivity Reactions Post-market safety reporting has identified copper hypersensitivity in women receiving copper-containing intrauterine devices, providing evidence that patients may experience hypersensitivity reactions when exposed to this metal. If hypersensitivity reactions (e.g., pruritis, angioedema, dyspnea, rash, urticaria) occur in patients receiving Cupric Chloride Injection in parenteral nutrition, discontinue the product and initiate appropriate medical treatment (see CONTRAINDICATIONS ). Aluminum Toxicity 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 None known.
🆘 Overdosage ▾
OVERDOSAGE Acute copper toxicity has been reported in patients with oral, intravenous, or subcutaneous administration. Clinical manifestations included metallic taste, nausea, vomiting, diarrhea, abdominal pain, neurological signs, such as encephalopathy and multi-organ failure involving kidney, liver, blood and cardiovascular systems, which may be fatal. Chelating agents, such as D-penicillamine, can be used for treatment of acute toxicity.
Long-term administration of parenteral copper above the recommended dosage may result in significant accumulation of copper in the liver, brain and other tissues with possible organ damage (see WARNINGS: Hepatic Accumulation ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Copper is an essential nutrient which serves as a cofactor for serum ceruloplasmin, an oxidase necessary for proper formation of the iron carrier protein, transferrin. Copper also helps maintain normal rates of red and white blood cell formation. Providing copper during TPN helps prevent development of the following deficiency symptoms: Leukopenia, neutropenia, anemia, depressed ceruloplasmin levels, impaired transferrin formation, secondary iron deficiency and osteoporosis.
Normal serum copper values range from 80 mcg/dl to 163 mcg/dl (mean, approximately 110 mcg/dl). The serum copper level at which deficiency symptoms appear is not precisely defined. In the plasma, about 7% of copper is bound to albumin and amino acids.
In the liver, about 93% of copper is bound to ceruloplasmin and released to the serum. The daily turnover of copper through ceruloplasmin is approximately 0.5 mg. Copper is primarily excreted through the bile and into the gastrointestinal tract where it is not reabsorbed.
Copper is also eliminated through the kidneys.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Cupric Chloride Injection USP, 0.4 mg/mL is available as sterile, clear, colorless to light blue color solution filled in 10 mL polypropylene vial with gray rubber stopper and orange flip-off seal. It is supplied as follows: 4 mg/10 mL (0.4 mg/mL) 1 Single-Dose Vial: NDC 80830-2301-1 25 Vials in 1 Carton: NDC 80830-2301-5 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Amneal Pharmaceuticals Pvt.
Ltd. Ahmedabad 382110, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2025-03
📋 Description ▾
DESCRIPTION Cupric chloride injection USP, 0.4 mg/mL is a sterile, clear, colorless to light blue color, nonpyrogenic solution intended for use as an additive to intravenous solutions for total parenteral nutrition (TPN). Each mL of solution contains 1.07 mg cupric chloride dihydrate; 9 mg sodium chloride and water for injection. The solution contains no bacteriostat, antimicrobial agent or added buffer.
The pH is 2.0 (1.5 to 2.5); product may contain hydrochloric acid and sodium hydroxide for pH adjustment. The osmolarity is 0.327 mOsmol/mL (calc.). Cupric chloride, USP is chemically designated cupric chloride, dihydrate.
Its molecular weight is 170.48 g/mol. The molecular formula is CuCl 2 • 2H 2 O and the structural formula is: Cupric chloride, USP is a blue to blue-green crystalline compound freely soluble in water, soluble in alcohol and slightly soluble in ether. Sodium chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water.
The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The small amount of water vapor that can pass through the plastic container wall will not significantly alter the drug concentration.
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⚠️ Precautions ▾
PRECAUTIONS Laboratory Tests Twice monthly serum assays for copper and/or ceruloplasmin are suggested for monitoring copper concentrations in long-term TPN patients. As ceruloplasmin is a cuproenzyme, ceruloplasmin assays may be depressed secondary to copper deficiency. Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term animal studies to evaluate the carcinogenic potential of cupric chloride injection have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when cupric chloride injection, 0.4 mg/mL is administered to a nursing woman. Pediatric Use The safety and effectiveness of cupric chloride injection have been established in pediatric patients receiving parenteral nutrition (see DOSAGE AND ADMINISTRATION ).
Pregnancy Animal reproduction studies have not been conducted with cupric chloride. It is also not known whether cupric chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Cupric chloride should be given to a pregnant woman only if clearly indicated.
Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between 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 other drug therapy. Hepatic Impairment Copper is primarily excreted in the bile.
Excretion is decreased in patients with cholestasis and/or cirrhosis (see CLINICAL PHARMACOLOGY ). Hepatic accumulation of copper has been reported with long-term administration of parenteral nutrition at dosages higher than recommended (see WARNINGS: Hepatic Accumulation ). For patients with cholestasis or cirrhosis, monitor hepatic and biliary function during long-term administration of cupric chloride injection.
If a patient develops signs or symptoms of hepatobiliary disease during use of cupric chloride injection, obtain serum concentrations of copper and ceruloplasmin.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 80830-2301-1 Cupric Chloride Injection USP, 4 mg/10 mL (0.4 mg/mL) Vial label Rx only Amneal Pharmaceuticals LLC NDC 80830-2301-5 Cupric Chloride Injection USP, 4 mg/10 mL (0.4 mg/mL) Carton label Rx only Amneal Pharmaceuticals LLC 2 1
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| NDC identity (package / product / labeler codes) | ✓ Available |
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| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
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| 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) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |