0517-8510 NDC - MULTITRACE-5 (TRACE ELEMENTS 5)

Drug Information

Product NDC: 0517-8510

Proprietary Name: Multitrace-5

Non Proprietary Name: Trace Elements 5

Active Ingredient(s):
  • 20.5 ug/mL CHROMIC CHLORIDE;
  • 1.57 mg/mL CUPRIC SULFATE;
  • .308 mg/mL MANGANESE SULFATE;
  • 32.7 ug/mL SELENIOUS ACID;
  • 4.39 mg/mL ZINC SULFATE HEPTAHYDRATE


Administration Route(s): INTRAVENOUS

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • Copper Absorption Inhibitor [EPC];
  • Decreased Copper Ion Absorption [PE];
  • Magnetic Resonance Contrast Activity [MoA];
  • Paramagnetic Contrast Agent [EPC]

Labeler Information

Labeler Name: American Regent, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:2/17/1994

Package Information

No. Package Code Package Description Billing Unit
10517-8510-2525 VIAL, MULTI-DOSE in 1 TRAY (0517-8510-25) / 10 mL in 1 VIAL, MULTI-DOSEML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0517-8510The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEMultitrace-5The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMETrace Elements 5The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE2/17/1994This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEAmerican Regent, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE HEPTAHYDRATEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH20.5; 1.57; .308; 32.7; 4.39 
ACTIVE INGRED UNITug/mL; mg/mL; mg/mL; ug/mL; mg/mL 
PHARM CLASSESCopper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC] 

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This page was last updated on: 2/1/2023