Moxifloxacin
These highlights do not include all the information needed to use MOXIFLOXACIN OPHTHALMIC SOLUTION, USP safely and effectively. See full prescribing information for MOXIFLOXACIN OPHTHALMIC SOLUTION, USP.MOXIFLOXACIN ophthalmic solution, USP 0.5% Sterile topical ophthalmic solutionInitial U.S. Approval: 1999
Approved
Approval ID
1cc031d7-0766-41c0-b5b3-35119c850e23
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 18, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code72162-2107
Application NumberANDA090080
Product Classification
M
Marketing Category
C73584
G
Generic Name
moxifloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 19, 2023
FDA Product Classification
INGREDIENTS (6)
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATEActive
Quantity: 5 mg in 1 mL
Code: B8956S8609
Classification: ACTIB