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Moxifloxacin

These highlights do not include all the information needed to use MOXIFLOXACIN INJECTION safely and effectively. See full prescribing information for MOXIFLOXACIN INJECTION.MOXIFLOXACIN injection, for intravenous use Initial U.S. Approval: 1999 To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin injection and other antibacterial drugs, moxifloxacin injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Approved
Approval ID

6067b2ee-2171-49bb-aa07-1d401ebf4f2e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 28, 2017

Manufacturers
FDA

Fresenius Kabi Norge AS

DUNS: 731170932

Products 1

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

MOXIFLOXACIN HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66298-8507
Application NumberNDA205572
Product Classification
M
Marketing Category
C73594
G
Generic Name
MOXIFLOXACIN HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 28, 2017
FDA Product Classification

INGREDIENTS (4)

SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT
MOXIFLOXACIN HYDROCHLORIDEActive
Quantity: 400 mg in 250 mL
Code: C53598599T
Classification: ACTIM
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT

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Moxifloxacin - FDA Drug Approval Details