CUPRIC CHLORIDE .4 mg/mL Injection, Solution
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 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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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.
3 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.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $63.07 | $15,767.98 / 250 ml |
| 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?
🔁 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/mLthis 51754-0103-04 | Exela | 25 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/mL 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?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51754-0103-03 | 10 VIAL, SINGLE-DOSE in 1 CARTON (51754-0103-3) / 10 mL in 1 VIAL, SINGLE-DOSE | 2023-02-01 | Active |
| 51754-0103-04 You're viewing this | 25 VIAL, SINGLE-DOSE in 1 CARTON (51754-0103-4) / 10 mL in 1 VIAL, SINGLE-DOSE | 2023-02-01 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 51754-0103-04?
What NDC number is used to bill for this package of CUPRIC CHLORIDE .4 mg/mL Injection, Solution?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Why is there no price listed?
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Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Cupric Chloride Injection, USP 0.4 mg/mL is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (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, USP contains 0.4 mg/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 is 0.5 to 1.5 mg copper/day (1.25 to 3.75 mL/day).
For pediatric patients, the suggested additive dosage is 20 mcg copper/kg/day (0.05 mL/kg/day). Infants weighing less than 1,500 gm may have increased requirements because of their low body reserves and increased requirements for growth. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
(See PRECAUTIONS .)
⛔ Contraindications ▾
CONTRAINDICATIONS None known.
⚠️ Warnings ▾
WARNINGS Direct intramuscular or intravenous injection of Cupric Chloride Injection, USP 0.4 mg/mL is contraindicated, as the acidic pH of the solution (2) may cause considerable tissue irritation. Liver and/or biliary tract dysfunction may require omission or reduction of copper and manganese doses because these elements are primarily eliminated in the bile. 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 None known.
🔄 Drug Interactions ▾
Drug Interactions Cupric ion may degrade ascorbic acid in total parenteral nutrition (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.
🤰 Pregnancy ▾
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.
🧒 Pediatric Use ▾
Pediatric Use (See DOSAGE AND ADMINISTRATION section.) There are limited data in infants weighing less than 1,500 grams.
🧓 Geriatric Use ▾
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.
🆘 Overdosage ▾
OVERDOSAGE Copper toxicity can produce prostration, behavior change, diarrhea, progressive marasmus, hypotonia, photophobia and peripheral edema. Such symptoms have been reported with a serum copper level of 286 mcg/dl. Copper toxicity can also result in hemolysis and liver toxicity, including hepatic necrosis which may be fatal. D-penicillamine has been reported effective as an antidote.
🧬 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 to 163 mcg/dl (mean, approximately 110 mcg/dl). The serum copper level at which deficiency symptoms appear is not precisely defined. A serum value of 9 mcg copper/dl was reported for one TPN patient who received no copper.
The daily turnover of copper through ceruloplasmin is approximately 0.5 mg. Excretion of copper is through the bile (80%), directly through the intestinal wall (16%) and in urine (4%).
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Cupric Chloride Injection, USP 0.4 mg/mL is supplied in 10 mL plastic vials (NDC 51754-0103-1) available in a carton of 10 (NDC 51754-0103-3) and a carton of 25 (NDC 51754-0103-4). Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645 Revised: 11/2022 Logo
📋 Description ▾
DESCRIPTION Cupric Chloride Injection, USP 0.4 mg/mL is a sterile, 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 and 9 mg sodium chloride. 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 (CuCl 2 • 2H 2 O), a crystalline compound freely soluble in water.
Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The vial is fabricated from cyclic olefin copolymer.