FDA.reportPublic FDA data

Multrys

Product NDC
0517-9302
11-digit product format
005179302
Labeler code
0517
Product ID
0517-9302_5c07b457-1143-440c-9975-90c16852a103
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trace Elements Injection 4
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
American Regent, Inc.
Application
NDA209376
Marketing category
NDA
Marketing start
2021-09-01
Substance
CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
Active strength
150; 8.22; 9.8; 2470 ug/mL; ug/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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Multrys
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CUPRIC SULFATE150 ug/mL
MANGANESE SULFATE8.22 ug/mL
SELENIOUS ACID9.8 ug/mL
ZINC SULFATE2470 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLRX7AJ16DT, W00LYS4T26, F6A27P4Q4R, 89DS0H96TB
Rxcui2568573, 2568579

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
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
0517-9302-01Multrys1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION14
0517-9302-25Multrys25 in 1 TRAYINJECTION, SOLUTION254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-9302MULTRYS (TRACE ELEMENTS INJECTION 4) INJECTION, SOLUTION [AMERICAN REGENT, INC.]4Current NDC, Legacy NDC, 2 package rows20240824_995f1efa-aca0-4b6c-9099-f8e757c2133a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2568573copper sulfate 150 MCG (copper 60 MCG) / manganese sulfate 8.22 MCG (manganese 3 MCG) / selenious acid 9.8 MCG (selenium 6 MCG) / zinc sulfate 2470 MCG (zinc 1000 MCG) in 1 ml InjectionPSN995f1efa-aca0-4b6c-9099-f8e757c2133a4
2568579Multrys trace elements 4 in 1 ml InjectionPSN995f1efa-aca0-4b6c-9099-f8e757c2133a4
25685791 ML copper sulfate 0.15 MG/ML / manganese sulfate 0.00822 MG/ML / selenious acid 0.0098 MG/ML / zinc sulfate 2.47 MG/ML Injection [Multrys]SBD995f1efa-aca0-4b6c-9099-f8e757c2133a4
25685731 ML copper sulfate 0.15 MG/ML / manganese sulfate 0.00822 MG/ML / selenious acid 0.0098 MG/ML / zinc sulfate 2.47 MG/ML InjectionSCD995f1efa-aca0-4b6c-9099-f8e757c2133a4
25685731 ML copper sulfate 0.15 MG/ML / manganese sulfate 0.00822 MG/ML / selenious acid 0.0098 MG/ML / ZnSO4 2.47 MG/ML InjectionSY995f1efa-aca0-4b6c-9099-f8e757c2133a4
25685791 ML copper sulfate 0.15 MG/ML / manganese sulfate 0.00822 MG/ML / selenious acid 0.0098 MG/ML / ZnSO4 2.47 MG/ML Injection [Multrys]SY995f1efa-aca0-4b6c-9099-f8e757c2133a4
2568579Multrys (copper sulfate 150 MCG (copper 60 MCG) / manganese sulfate 8.22 MCG (manganese 3 MCG) / selenious acid 9.8 MCG (selenium 6 MCG) / zinc sulfate 2470 MCG (zinc 1000 MCG)) per 1 ml InjectionSY995f1efa-aca0-4b6c-9099-f8e757c2133a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0517-9302-01005179302011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
0517-9302-250051793022525 VIAL, SINGLE-DOSE in 1 TRAY (0517-9302-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9302-01) 2021-09-010000-00-00NoNoCurrent