Levofloxacin

Basic Information

Product Name

Levofloxacin

FDA Product Code

36000-048

Regulatory Information

NDC Product Code

36000-048

Application Number

ANDA091397

Marketing Category

C73584

Effective Date

August 1, 2018

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for Levofloxacin Injection, 25 mg/mL and Levofloxacin Injection in 5% Dextrose, 5 mg/mL. Initial U.S. Approval: 1996

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

DEXTROSE, UNSPECIFIED FORM

Code: IY9XDZ35W2

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

LEVOFLOXACIN

Quantity: 5 mg in 1 mL

Code: 6GNT3Y5LMF

Class Code: ACTIM

Active Moieties

LEVOFLOXACIN ANHYDROUS

Code: RIX4E89Y14

Basic Information

Regulatory Information

Company Information

Active Ingredients

DEXTROSE, UNSPECIFIED FORM

SODIUM HYDROXIDE

HYDROCHLORIC ACID

Active Moieties

LEVOFLOXACIN ANHYDROUS