ALTAFLUOR

Product NDC
59390-218
11-digit product format
593900218
Labeler code
59390
Product ID
59390-218_22a50c28-e476-4966-b68c-065a4b8e157f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluorescein Sodium and Benoxinate Hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Altaire Pharmaceuticals Inc.
Application
NDA208582
Marketing category
NDA
Marketing start
2018-03-01
Substance
BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM
Active strength
4; 2.5 mg/mL; mg/mL
Pharmacologic classes
Diagnostic Dye [EPC], Dyes [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ALTAFLUOR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENOXINATE HYDROCHLORIDE4 mg/mL
FLUORESCEIN SODIUM2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE4U49K15, 93X55PE38X
Rxcui2099132, 2099522

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f43a274-9585-47cb-b427-0eb3e578384dProduct name120250623
4a998fa9-995e-4ea5-97ef-93a559305758Product name120200706
c94ccba7-2a03-4a3e-a891-d62a57340fb2Product name120180215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59390-218-05ALTAFLUOR5 mL in 1 BOTTLE, DROPPERSOLUTION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59390-218-05ML - Milliliter59390-218a64d4785-c6d2-46e3-8fcb-f952d523421812018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59390-218ALTAFLUOR (FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE) SOLUTION [ALTAIRE PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 1 package rows20221203_54017304-e680-4129-b52a-69cb9810af76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2099522Altafluor 0.4 % / 0.25 % Ophthalmic SolutionPSN54017304-e680-4129-b52a-69cb9810af765
2099132benoxinate HCl 0.4 % / fluorescein sodium 0.25 % Ophthalmic SolutionPSN54017304-e680-4129-b52a-69cb9810af765
2099522benoxinate hydrochloride 4 MG/ML / fluorescein sodium 2.5 MG/ML Ophthalmic Solution [Altafluor]SBD54017304-e680-4129-b52a-69cb9810af765
2099132benoxinate hydrochloride 4 MG/ML / fluorescein sodium 2.5 MG/ML Ophthalmic SolutionSCD54017304-e680-4129-b52a-69cb9810af765
2099522Altafluor (benoxinate HCl 0.4 % / fluorescein sodium 0.25 % ) Ophthalmic DropsSY54017304-e680-4129-b52a-69cb9810af765
2099132benoxinate hydrochloride 0.4 % / fluorescein sodium 0.25 % Ophthalmic DropsSY54017304-e680-4129-b52a-69cb9810af765

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59390-218-05593900218055 mL in 1 BOTTLE, DROPPER (59390-218-05) 5 ml2018-03-010000-00-00NoNoCurrent