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Multitrace-5

MULTITRACE - 5 (TRACE ELEMENTS INJECTION 5, USP)

Approved
Approval ID

ef63bbe8-ebf8-436c-b38d-6cb92bc91ac0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 25, 2019

Manufacturers
FDA

American Regent, Inc.

DUNS: 002033710

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Trace Elements 5

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0517-8510
Product Classification
G
Generic Name
Trace Elements 5
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 25, 2019
FDA Product Classification

INGREDIENTS (9)

CUPRIC SULFATEActive
Quantity: 1.57 mg in 1 mL
Code: LRX7AJ16DT
Classification: ACTIM
MANGANESE SULFATEActive
Quantity: 0.308 mg in 1 mL
Code: W00LYS4T26
Classification: ACTIM
CHROMIC CHLORIDEActive
Quantity: 20.5 ug in 1 mL
Code: KB1PCR9DMW
Classification: ACTIM
SELENIOUS ACIDActive
Quantity: 32.7 ug in 1 mL
Code: F6A27P4Q4R
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ZINC SULFATE HEPTAHYDRATEActive
Quantity: 4.39 mg in 1 mL
Code: N57JI2K7WP
Classification: ACTIM

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Multitrace-5 - FDA Drug Approval Details