Levofloxacin
These highlights do not include all the information needed to use Levofloxacin safely and effectively. See full prescribing information for Levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996
Approved
Approval ID
56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2014
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
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 Code33261-793
Application NumberANDA090367
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2014
FDA Product Classification
INGREDIENTS (13)
LEVOFLOXACINActive
Quantity: 500 mg in 1 1
Code: 6GNT3Y5LMF
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Levofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-891
Application NumberANDA090367
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2014
FDA Product Classification
INGREDIENTS (12)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
LEVOFLOXACINActive
Quantity: 250 mg in 1 1
Code: 6GNT3Y5LMF
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Levofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-876
Application NumberANDA090367
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2014
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LEVOFLOXACINActive
Quantity: 750 mg in 1 1
Code: 6GNT3Y5LMF
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT