Moxifloxacin
These highlights do not include all the information needed to use MOXIFLOXACIN OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for MOXIFLOXACIN OPHTHALMIC SOLUTION.MOXIFLOXACIN ophthalmic solution, for topical ophthalmic useInitial U.S. Approval: 1999
Approved
Approval ID
7ae6355d-aaa3-48e4-a3d5-50f7ca8dfe08
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2021
Manufacturers
FDA
Akorn
DUNS: 117696770
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Moxifloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17478-519
Application NumberANDA202916
Product Classification
M
Marketing Category
C73584
G
Generic Name
Moxifloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 6, 2017
FDA Product Classification
INGREDIENTS (6)
Moxifloxacin HydrochlorideActive
Quantity: 5 mg in 1 mL
Code: C53598599T
Classification: ACTIM
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Boric AcidInactive
Code: R57ZHV85D4
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT