Fluorescein Sodium and Benoxinate Hydrochloride
These highlights do not include all the information needed to use FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE OPHTHALMIC SOLUTION, 0.3%/0.4% safely and effectively. See full prescribing information for
Approved
Approval ID
580c7f94-7013-4b7a-9010-4d37186f5758
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 19, 2020
Manufacturers
FDA
Oceanside Pharmaceuticals
DUNS: 832011691
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluorescein Sodium and Benoxinate Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68682-732
Application NumberNDA211039
Product Classification
M
Marketing Category
C73605
G
Generic Name
Fluorescein Sodium and Benoxinate Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 19, 2020
FDA Product Classification
INGREDIENTS (6)
FLUORESCEIN SODIUMActive
Quantity: 2.6 mg in 1 mL
Code: 93X55PE38X
Classification: ACTIB
BENOXINATE HYDROCHLORIDEActive
Quantity: 4.4 mg in 1 mL
Code: 0VE4U49K15
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT