Moxifloxacin Hydrochloride
These highlights do not include all the information needed to use MOXIFLOXACIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MOXIFLOXACIN HYDROCHLORIDE TABLETS. MOXIFLOXACIN HYDROCHLORIDE tablets, for oral useInitial U.S. Approval:1999
Approved
Approval ID
3c442cca-47f5-48e5-b718-c09413911687
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2019
Manufacturers
FDA
Novel Laboratories, Inc.
DUNS: 793518643
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Moxifloxacin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code40032-034
Application NumberANDA207285
Product Classification
M
Marketing Category
C73584
G
Generic Name
Moxifloxacin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2019
FDA Product Classification
INGREDIENTS (10)
MOXIFLOXACIN HYDROCHLORIDEActive
Quantity: 400 mg in 1 1
Code: C53598599T
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT