ALTAFLUOR
These highlights do not include all the information needed to use ALTAFLUOR BENOX safely and effectively. See full prescribing information for ALTAFLUOR BENOX. Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/ 0.4% for topical ophthalmic use Initial U.S. Approval: 2017
Approved
Approval ID
54017304-e680-4129-b52a-69cb9810af76
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2017
Manufacturers
FDA
Altaire Pharmaceuticals Inc.
DUNS: 786790378
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 Code59390-218
Application NumberNDA208582
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fluorescein Sodium and Benoxinate Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 2, 2022
FDA Product Classification
INGREDIENTS (8)
FLUORESCEIN SODIUMActive
Quantity: 2.5 mg in 1 mL
Code: 93X55PE38X
Classification: ACTIM
CHLOROBUTANOLInactive
Quantity: 11 mg in 1 mL
Code: HM4YQM8WRC
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
BENOXINATE HYDROCHLORIDEActive
Quantity: 4 mg in 1 mL
Code: 0VE4U49K15
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT