Multitrace-5

Product NDC
0517-8201
Requested package NDC
0517-8201-25
11-digit product format
005178201
Labeler code
0517
Product ID
0517-8201_084307ad-f65d-4fbc-9177-6e26f664667f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trace Elements 5
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
American Regent, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1993-12-17
Marketing end
0000-00-00
Substance
ZINC SULFATE HEPTAHYDRATE; CUPRIC SULFATE; MANGANESE SULFATE; CHROMIC CHLORIDE; SELENIOUS ACID
Active strength
22 mg/mL; mg/mL; mg/mL; ug/mL; ug/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
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0517-82010517-8201-25DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-8201-25ML - Milliliter0517-82017f56e071-f4c4-4a63-bd20-7243df8b984d12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHROMIC CHLORIDEACTIVE INGREDIENTKB1PCR9DMWMULTITRACE-5 (TRACE ELEMENTS 5) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
CUPRIC SULFATEACTIVE INGREDIENTLRX7AJ16DTMULTITRACE-5 (TRACE ELEMENTS 5) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
MANGANESE SULFATEACTIVE INGREDIENTW00LYS4T26MULTITRACE-5 (TRACE ELEMENTS 5) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
SELENIOUS ACIDACTIVE INGREDIENTF6A27P4Q4RMULTITRACE-5 (TRACE ELEMENTS 5) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
ZINC SULFATE HEPTAHYDRATEACTIVE INGREDIENTN57JI2K7WPMULTITRACE-5 (TRACE ELEMENTS 5) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
CHROMIC CATIONACTIVE MOIETYX1N4508KF1MULTITRACE-5 (TRACE ELEMENTS 5) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
CUPRIC CATIONACTIVE MOIETY8CBV67279LMULTITRACE-5 (TRACE ELEMENTS 5) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
MANGANESE CATION (2+)ACTIVE MOIETYH6EP7W5457MULTITRACE-5 (TRACE ELEMENTS 5) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
SELENIOUS ACIDACTIVE MOIETYF6A27P4Q4RMULTITRACE-5 (TRACE ELEMENTS 5) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
ZINC CATIONACTIVE MOIETY13S1S8SF37MULTITRACE-5 (TRACE ELEMENTS 5) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMULTITRACE-5 (TRACE ELEMENTS 5) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFMULTITRACE-5 (TRACE ELEMENTS 5) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RMULTITRACE-5 (TRACE ELEMENTS 5) INJECTION, SOLUTION, CONCENTRATE [AMERICAN REGENT, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0517-8201-250051782012525 VIAL, SINGLE-DOSE in 1 TRAY (0517-8201-25) > 1 mL in 1 VIAL, SINGLE-DOSE1993-12-170000-00-00NoNoCurrent