Moxifloxacin Hydrochloride
These highlights do not include all the information needed to use MOXIFLOXACIN TABLETS safely and effectively. See full prescribing information for MOXIFLOXACIN TABLETS. MOXIFLOXACIN tablets, for oral useInitial U.S. Approval: 1999
Approved
Approval ID
9ee0ccfd-6920-4560-a3b2-6bb88190b0dc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2022
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
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 Code0093-7387
Application NumberANDA077437
Product Classification
M
Marketing Category
C73584
G
Generic Name
Moxifloxacin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2022
FDA Product Classification
INGREDIENTS (10)
MOXIFLOXACIN HYDROCHLORIDEActive
Quantity: 400 mg in 1 1
Code: C53598599T
Classification: ACTIM
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT