Moxifloxacin Hydrochloride
Moxifloxacin Hydrochloride Tablets 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 tablet, film-coated for oral use Initial U.S. Approval: 1999
Approved
Approval ID
371ca7b2-c62d-ef4b-3076-890b385bfff8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 16, 2022
Manufacturers
FDA
AvPAK
DUNS: 832926666
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 Code50268-576
Application NumberANDA202632
Product Classification
M
Marketing Category
C73584
G
Generic Name
Moxifloxacin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 16, 2022
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MOXIFLOXACIN HYDROCHLORIDEActive
Quantity: 400 mg in 1 1
Code: C53598599T
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT