Levofloxacin
These highlights do not include all the information needed to use LEVOFLOXACIN INJECTION safely and effectively. See full prescribing information for LEVOFLOXACIN INJECTION. LEVOFLOXACIN injection, for intravenous use Initial U.S. Approval: 1996
Approved
Approval ID
4d400bf9-988f-42ec-93f1-e71a93a324b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2021
Manufacturers
FDA
AuroMedics Pharma LLC
DUNS: 968961354
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-156
Application NumberANDA202328
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levofloxacin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 10, 2021
FDA Product Classification
INGREDIENTS (4)
LEVOFLOXACINActive
Quantity: 500 mg in 20 mL
Code: 6GNT3Y5LMF
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Levofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-157
Application NumberANDA202328
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levofloxacin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 10, 2021
FDA Product Classification
INGREDIENTS (4)
LEVOFLOXACINActive
Quantity: 750 mg in 30 mL
Code: 6GNT3Y5LMF
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT