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FDA Approval

Multitrace-5

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
American Regent, Inc.
DUNS: 002033710
Effective Date
April 25, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cupric sulfate(1.57 mg in 1 mL)
Manganese sulfate(0.308 mg in 1 mL)
Chromic chloride(20.5 ug in 1 mL)
Selenious acid(32.7 ug in 1 mL)
Zinc Sulfate Hydrate(4.39 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

American Regent, Inc.

American Regent, Inc.

002033710

Products1

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

Multitrace-5

Product Details

NDC Product Code
0517-8510
Route of Administration
INTRAVENOUS
Effective Date
April 25, 2019
Code: LRX7AJ16DTClass: ACTIMQuantity: 1.57 mg in 1 mL
Code: W00LYS4T26Class: ACTIMQuantity: 0.308 mg in 1 mL
Code: KB1PCR9DMWClass: ACTIMQuantity: 20.5 ug in 1 mL
Code: F6A27P4Q4RClass: ACTIBQuantity: 32.7 ug in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: N57JI2K7WPClass: ACTIMQuantity: 4.39 mg in 1 mL
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