Levofloxacin
These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS, safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
Approved
Approval ID
fc165a6d-24b0-4753-a7ac-94a134dca0d3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 6, 2023
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
Products 3
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 Code33342-532
Application NumberANDA200839
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 6, 2023
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LEVOFLOXACINActive
Quantity: 500 mg in 1 1
Code: 6GNT3Y5LMF
Classification: ACTIM
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Levofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-533
Application NumberANDA200839
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 6, 2023
FDA Product Classification
INGREDIENTS (8)
LEVOFLOXACINActive
Quantity: 750 mg in 1 1
Code: 6GNT3Y5LMF
Classification: ACTIM
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Levofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-531
Application NumberANDA200839
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 6, 2023
FDA Product Classification
INGREDIENTS (9)
LEVOFLOXACINActive
Quantity: 250 mg in 1 1
Code: 6GNT3Y5LMF
Classification: ACTIM
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT