FDA.reportPublic FDA data

Multitrace -4 Pediatric

Product NDC
0517-9203
11-digit product format
005179203
Labeler code
0517
Product ID
0517-9203_8e5be3e5-1916-4d19-87ab-e2092f5d4c5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trace Elements 4
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
American Regent, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1993-12-09
Substance
CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; ZINC SULFATE HEPTAHYDRATE
Active strength
5.12; .4; 77; 4.39 ug/mL; mg/mL; ug/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Multitrace -4 Pediatric
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHROMIC CHLORIDE5.12 ug/mL
CUPRIC SULFATE.4 mg/mL
MANGANESE SULFATE77 ug/mL
ZINC SULFATE HEPTAHYDRATE4.39 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKB1PCR9DMW, LRX7AJ16DT, W00LYS4T26, N57JI2K7WP
Rxcui1293464, 1293466

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
015efbe7-5dcf-c8dc-f62d-817d23b49060Product name220250717
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-9203-25Multitrace -4 Pediatric3 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE34
0517-9203-25Multitrace -4 Pediatric25 in 1 TRAYINJECTION, SOLUTION, CONCENTRATE254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-9203-25ML - Milliliter0517-92031c4d38f9-2d65-4adb-8e03-ec4d6d32e0f312014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHROMIC CHLORIDEACTIVE INGREDIENTKB1PCR9DMWMULTITRACE -4 PEDIATRIC (TRACE ELEMENTS 4) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
CUPRIC SULFATEACTIVE INGREDIENTLRX7AJ16DTMULTITRACE -4 PEDIATRIC (TRACE ELEMENTS 4) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
MANGANESE SULFATEACTIVE INGREDIENTW00LYS4T26MULTITRACE -4 PEDIATRIC (TRACE ELEMENTS 4) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
ZINC SULFATE HEPTAHYDRATEACTIVE INGREDIENTN57JI2K7WPMULTITRACE -4 PEDIATRIC (TRACE ELEMENTS 4) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
CHROMIC CATIONACTIVE MOIETYX1N4508KF1MULTITRACE -4 PEDIATRIC (TRACE ELEMENTS 4) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
CUPRIC CATIONACTIVE MOIETY8CBV67279LMULTITRACE -4 PEDIATRIC (TRACE ELEMENTS 4) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
MANGANESE CATION (2+)ACTIVE MOIETYH6EP7W5457MULTITRACE -4 PEDIATRIC (TRACE ELEMENTS 4) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
ZINC CATIONACTIVE MOIETY13S1S8SF37MULTITRACE -4 PEDIATRIC (TRACE ELEMENTS 4) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMULTITRACE -4 PEDIATRIC (TRACE ELEMENTS 4) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFMULTITRACE -4 PEDIATRIC (TRACE ELEMENTS 4) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RMULTITRACE -4 PEDIATRIC (TRACE ELEMENTS 4) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-9203MULTITRACE -4 PEDIATRIC (TRACE ELEMENTS 4) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]4Current NDC, Legacy NDC, 2 package rows20190425_5ee6a685-3c35-467b-8d4d-79efdd0bfa8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293466Multitrace-4 Pediatric Solution for InjectionPSN5ee6a685-3c35-467b-8d4d-79efdd0bfa8e4
1293464trace elements 4 pediatric Solution for InjectionPSN5ee6a685-3c35-467b-8d4d-79efdd0bfa8e4
1293466chromic chloride 0.00512 MG/ML / copper sulfate 0.4 MG/ML / manganese sulfate 0.077 MG/ML / zinc sulfate 4.39 MG/ML Injectable Solution [Multitrace-4]SBD5ee6a685-3c35-467b-8d4d-79efdd0bfa8e4
1293464chromic chloride 0.00512 MG/ML / copper sulfate 0.4 MG/ML / manganese sulfate 0.077 MG/ML / zinc sulfate 4.39 MG/ML Injectable SolutionSCD5ee6a685-3c35-467b-8d4d-79efdd0bfa8e4
1293464chromic chloride 0.00512 MG/ML / Copper Sulfate 0.4 MG/ML / manganese sulfate 0.077 MG/ML / ZnSO4 4.39 MG/ML Injectable SolutionSY5ee6a685-3c35-467b-8d4d-79efdd0bfa8e4
1293466chromic chloride 0.00512 MG/ML / Copper Sulfate 0.4 MG/ML / manganese sulfate 0.077 MG/ML / ZnSO4 4.39 MG/ML Injectable Solution [Multitrace-4]SY5ee6a685-3c35-467b-8d4d-79efdd0bfa8e4
1293464chromic chloride 5.12 MCG (chromium 1 MCG) / copper sulfate 0.4 MG (copper 0.1 MG) / manganese sulfate 77 MCG (manganese 25 MCG) / zinc sulfate 4.39 MG (zinc 1 MG) per 1 ML Injectable SolutionSY5ee6a685-3c35-467b-8d4d-79efdd0bfa8e4
1293466Multitrace-4 Pediatric (chromic chloride 5.12 MCG (chromium 1 MCG) / copper sulfate 0.4 MG (copper 0.1 MG) / manganese sulfate 77 MCG (manganese 25 MCG) / zinc sulfate 4.39 MG (zinc 1 MG)) per 1 ML Injectable SolutionSY5ee6a685-3c35-467b-8d4d-79efdd0bfa8e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0517-9203-250051792032525 VIAL, SINGLE-DOSE in 1 TRAY (0517-9203-25) / 3 mL in 1 VIAL, SINGLE-DOSE1993-12-090000-00-00NoNoCurrent