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Multitrace -4 Pediatric Trace Elements 4 4.39 mg/mL; .4 mg/mL; 77 ug/mL; 5.12 ug/mL Injection, Solution, Concentrate — NDC 00517-9203-25 package photo

Multitrace -4 Pediatric Trace Elements 4 4.39 mg/mL; .4 mg/mL; 77 ug/mL; 5.12 ug/mL Injection, Solution, Concentrate

by American Regent, Inc. · 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9203-25) / 3 mL in 1 VIAL, SINGLE-DOSE
NDC 00517-9203-25
🏷️ FDA NDC (as labeled) 0517-9203-25 billing pads the labeler segment with a zero
Rx only On market Non-controlled
🗂️ Data synced Aug 27, 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

🆔 Identity & classification

FDA NDC (as labeled) 0517-9203-25
Product NDC 0517-9203
11-digit billing NDC 00517920325
NCPDP billing unit ML — per mL (volume)
RxCUI 1293464, 1293466
UNII N57JI2K7WP, LRX7AJ16DT, W00LYS4T26, KB1PCR9DMW
UPC 0305179203253
SPL Set ID 5ee6a685-3c35-467b-8d4d-79efdd0bfa8e
Established class (EPC) Copper Absorption Inhibitor; Paramagnetic Contrast Agent
Mechanism of action Magnetic Resonance Contrast Activity
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1993-12-09
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION, CONCENTRATE
Substance ZINC SULFATE HEPTAHYDRATE; CUPRIC SULFATE; MANGANESE SULFATE; CHROMIC CHLORIDE
GPI-14 79909904102010
GPI class Multitrace-4 Pediatric
GCN Seq No 039519
GCN 89005
HICL code 018264
Ingredient (HICL) Zinc/Copper/Mangan/Chromic Chl
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C3
Therapeutic class — intermediate (HIC2) Minerals
HIC3 code C3M
Therapeutic class — specific (HIC3) Mineral Replacement, Miscellaneous
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name MULTITRACE-4 VIAL
FDB brand name Multitrace-4
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0517-9203-25 — 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 → 00517-9203-25. 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.

🏭 Manufacturer & labeler

LabelerAmerican Regent, Inc.
Labeler code00517
First marketedDec 1993
Product typeHuman Prescription Drug
Portfolio72 products on file
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.

🩺 Clinical

Label name MULTITRACE-4 VIAL Ingredient Zinc/Copper/Mangan/Chromic Chl
🧪 What is this product?

Multitrace-4 Pediatric is a concentrated injection solution given intravenously that contains four trace elements: zinc, copper, manganese, and chromium. These minerals are typically added to intravenous nutrition support (parenteral nutrition) in pediatric patients who cannot receive adequate nutrition by mouth or feeding tube. Each trace element normally functions in the body to support enzyme activity, wound healing, immune function, and metabolism. This product is marketed without an approved FDA application.

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.

🧪 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 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.
  • UNII O40UQP6WCF
    A strong acid used in small amounts to adjust and maintain the pH balance of a medicine, helping ensure stability and proper dissolution of the active ingredients.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Multitrace -4 Pediatric 4.39 mg/mL; .4 mg/mL; 77 ug/mL; 5.12 ug/mLthis 00517-9203-25 American 25 vials — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
1993
On the market since
Dec 1993
📍
2026
Currently FDA-listed
33 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Trace Elements 4 — the ingredient across all brands.

Top reported reactions

Product Compounding Quality Issue2
Product Preparation Error2
Blood Sodium Increased1
Product Selection Error1

Reporter sex

4 reports
Male · 25%
Female · 75%
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00517-9203-25 You're viewing this 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9203-25) / 3 mL in 1 VIAL, SINGLE-DOSE 1993-12-09 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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 FDA registers it as 0517-9203-25, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00517-9203-25, written without dashes as 00517920325. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00517-9203-25, the first segment (00517) is the labeler code FDA assigned to American Regent, Inc.; the middle segment (9203) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (25) identifies this exact package size and type. Together they name one specific package of one specific product.
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 American Regent, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
American Regent, Inc. 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 59 words ▾

INDICATIONS AND USAGE This formulation is indicated for use as a supplement to intravenous solutions given for TPN for children up to 11 years of age. Administration of the solution in TPN solutions helps to maintain plasma levels of zinc, copper, manganese, and chromium and to prevent depletion of endogenous stores of these trace elements and subsequent deficiency symptoms.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Each mL of the solution provides Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg, and is administered intravenously only after dilution to a minimum of 1:200. The suggested dosage ranges for the four trace elements are: ZINC : For full term infants and children, 100 mcg zinc/kg/day is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day is suggested.

COPPER : For pediatric patients, the suggested additive dosage level is 20 mcg copper/kg/day. The normal plasma range for copper is approximately 80 to 160 mcg/100 mL. MANGANESE : For pediatric patients, a dosage level of 2 to 10 mcg manganese/kg/day is recommended.

CHROMIUM : For pediatric patients, the suggested additive dosage level is 0.14 to 0.20 mcg/kg/day. Periodic monitoring of plasma levels of Zinc, Copper, Manganese, and Chromium is suggested as a guideline for administration. Aseptic addition of MULTITRACE® - 4 PEDIATRIC to parenteral nutrition solutions under a laminar flow hood is recommended.

The trace elements present in MULTITRACE® - 4 PEDIATRIC are physically compatible with the electrolytes and vitamins usually present in parenteral nutrition formulations. Do not directly mix ascorbic acid injection with copper or selenium containing parenteral products in the same syringe or vial, as this admixture may cause the formation of an insoluble precipitate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).

⛔ Contraindications 25 words ▾

CONTRAINDICATIONS MULTITRACE ® - 4 PEDIATRIC should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.

⚠️ Warnings 122 words ▾

WARNINGS Copper and Manganese are eliminated via the bile. In patients with severe liver dysfunction and/or biliary tract obstruction, decreasing or omitting copper and manganese supplements entirely may be necessary. 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 33 words ▾

ADVERSE REACTIONS The amounts of ZINC, COPPER, MANGANESE, AND CHROMIUM in the solution are very small and toxicity symptoms due to these trace elements at suggested dosage levels are considered unlikely to occur.

🤰 Pregnancy 36 words ▾

Pregnancy Teratogenic Effects Pregnancy Category C: Safety for use in pregnancy has not been established. Use of MULTITRACE ® - 4 PEDIATRIC in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.

🆘 Overdosage 193 words ▾

OVERDOSAGE Symptoms of ZINC overdose resulting from oral ingestion of Zinc Sulfate in large amounts have resulted in death. Symptoms included nausea, vomiting, dehydration, electrolyte imbalances, dizziness, abdominal pain, lethargy and incoordination. Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemia patients without toxic manifestations.

Normal plasma levels for Zinc vary from approximately 88 to 112 mcg/100 mL. Plasma levels sufficient to produce symptoms of toxic manifestations are not known. Calcium supplements may confer a protective effect against Zinc toxicity.

Symptoms of COPPER toxicity reported in literature include prostration, behavior change, diarrhea, progressive marasmus, hypotonia, photophobia and peripheral edema. D-penicillamine has been reported effective as an antidote. MANGANESE toxicity has not been reported in patients receiving TPN.

Neither have reports of manganese toxicity from excessive intake in foods and/or beverages been published. Symptoms of CHROMIUM toxicity include nausea, vomiting, ulcers and gastrointestinal tract, renal and hepatic damage, and abnormalities of the central nervous system culminating in convulsions and coma. Trivalent Chromium administered intravenously to TPN patients has been shown to be nontoxic when given at dosage levels up to 250 mcg/day for two consecutive weeks.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY ZINC has been identified as a cofactor for over 70 different enzymes, including carbonic anhydrase, alkaline phosphatase, lactic dehydrogenase and both RNA and DNA polymerase. Zinc facilitates wound healing, helps maintain normal growth rates, normal skin hydration and senses of taste and smell. Providing zinc during TPN prevents development of the following deficiency symptoms: Parakeratosis, hypogeusia, anorexia, dysosmia, geophagia, hypogonadism, growth retardation and hepatosplenomegaly.

At plasma levels below 20 mcg zinc/100 mL, dermatitis followed by alopecia has been reported for TPN patients. COPPER is essential 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.

Scorbutic type bone changes seen in infants fed exclusively with copper-poor cow's milk are believed due to decreased activity of ascorbate oxidase, a cuproenzyme. Providing copper during TPN prevents development of the following deficiency symptoms: leukopenia, neutropenia, anemia, depressed ceruloplasmin levels, impaired transferrin formation and secondary iron deficiency. MANGANESE is an activator for enzymes such as polysaccharide polymerase, liver arginase, cholinesterase and pyruvate carboxylase.

Providing manganese during TPN prevents development of the following deficiency symptoms: nausea and vomiting, weight loss, dermatitis, and changes in growth and color of hair. CHROMIUM (trivalent) is part of glucose tolerance factor, and activator insulin-mediated reactions. Chromium helps to maintain normal glucose metabolism and peripheral nerve function.

Providing chromium during TPN prevents development of the following deficiency symptoms: impaired glucose tolerance, ataxia, peripheral neuropathy, and a confusional state similar to mild/moderate hepatic encephalopathy.

📦 How Supplied / Storage and Handling 49 words ▾

HOW SUPPLIED MULTITRACE ® - 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP) Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg. NDC 0517-9203-25 3 mL Single Dose Vial Packaged in boxes of 25 AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN9203 Rev. 8/18

📋 Description 110 words ▾

DESCRIPTION MULTITRACE ® - 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP) is a sterile, nonpyrogenic solution containing four Trace Elements for use as an additive for Total Parenteral Nutrition (TPN). Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg and Chromium 1 mcg. Each mL contains: Zinc Sulfate Heptahydrate 4.39 mg (equivalent to 1 mg Zinc); Cupric Sulfate Pentahydrate 0.4 mg (equivalent to 0.1 mg Copper); Manganese Sulfate Monohydrate 77 mcg (equivalent to 25 mcg Manganese); Chromic Chloride Hexahydrate 5.12 mcg (equivalent to 1 mcg Chromium); and Water for Injection, q.s. pH of the solution may have been adjusted with sulfuric acid and/or sodium hydroxide.

Preservative Free.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00517-9191-25 · American 00517-9302-25 · American →
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.