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
b43e9b51-568c-4d84-bbd1-d237120056c4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2024
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
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 Code31722-722
Application NumberANDA202801
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2024
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LEVOFLOXACINActive
Quantity: 500 mg in 1 1
Code: 6GNT3Y5LMF
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
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 Code31722-721
Application NumberANDA202801
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2024
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LEVOFLOXACINActive
Quantity: 250 mg in 1 1
Code: 6GNT3Y5LMF
Classification: ACTIM
Levofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-723
Application NumberANDA202801
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2024
FDA Product Classification
INGREDIENTS (9)
LEVOFLOXACINActive
Quantity: 750 mg in 1 1
Code: 6GNT3Y5LMF
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT