Moxifloxacin Ophthalmic
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 USP, 0.5% Sterile topical ophthalmic solution Initial U.S. Approval: 1999
Approved
Approval ID
c76f7d78-1e52-4557-a43b-cfc8e5842c80
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Moxifloxacin Ophthalmic
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-6248
Application NumberANDA208778
Product Classification
M
Marketing Category
C73584
G
Generic Name
Moxifloxacin Ophthalmic
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 18, 2020
FDA Product Classification
INGREDIENTS (6)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MOXIFLOXACIN HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: C53598599T
Classification: ACTIM