AK-FLUOR

Product NDC
17478-250
11-digit product format
174780250
Labeler code
17478
Product ID
17478-250_52511566-69ed-499f-aced-28825ea3c81a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluorescein sodium
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Akorn
Application
NDA022186
Marketing category
NDA
Marketing start
2008-10-01
Marketing end
0000-00-00
Substance
FLUORESCEIN SODIUM
Active strength
250 mg/mL
Pharmacologic classes
Diagnostic Dye [EPC], Dyes [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-250-20AK-FLUOR12 in 1 PACKAGEINJECTION1212
17478-250-20AK-FLUOR2 mL in 1 VIAL, SINGLE-DOSEINJECTION212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-250-20ML - Milliliter17478-25005009756-78eb-42b8-b45a-681640fefe9612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fluorescein sodiumACTIVE INGREDIENT93X55PE38XAK-FLUOR (FLUORESCEIN SODIUM) INJECTION [AKORN]6
fluoresceinACTIVE MOIETYTPY09G7XIRAK-FLUOR (FLUORESCEIN SODIUM) INJECTION [AKORN]6
hydrochloric acidINACTIVE INGREDIENTQTT17582CBAK-FLUOR (FLUORESCEIN SODIUM) INJECTION [AKORN]6
sodium hydroxideINACTIVE INGREDIENT55X04QC32IAK-FLUOR (FLUORESCEIN SODIUM) INJECTION [AKORN]6
waterINACTIVE INGREDIENT059QF0KO0RAK-FLUOR (FLUORESCEIN SODIUM) INJECTION [AKORN]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-250AK-FLUOR (FLUORESCEIN SODIUM) INJECTION [AKORN]12Legacy NDC, 2 package rows20220911_a1823be3-a739-48bc-a3ea-ceb7cc5105ce.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-250-201747802502012 VIAL, SINGLE-DOSE in 1 PACKAGE (17478-250-20) > 2 mL in 1 VIAL, SINGLE-DOSE2008-10-010000-00-00NoNoCurrent