FLUORESCEIN

Product NDC
51662-1533
11-digit product format
516621533
Labeler code
51662
Product ID
51662-1533_c915cb71-f04b-2377-e053-2995a90a5d92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUORESCEIN
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA022186
Marketing category
NDA
Marketing start
2021-05-10
Substance
FLUORESCEIN SODIUM
Active strength
100 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
FLUORESCEIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUORESCEIN SODIUM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii93X55PE38X

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
51662-1533-2FLUORESCEIN1 in 1 POUCHINJECTION12
51662-1533-2FLUORESCEIN5 mL in 1 VIAL, SINGLE-DOSEINJECTION52
51662-1533-3FLUORESCEIN12 in 1 BOXINJECTION122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1533FLUORESCEIN INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, Legacy NDC, 3 package rows20210810_c1ffe119-7fba-940f-e053-2a95a90a7a17.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1533-2516621533021 in 1 POUCHHistorical
51662-1533-35166215330312 POUCH in 1 BOX (51662-1533-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2) / 5 mL in 1 VIAL, SINGLE-DOSE12 pouch2021-05-100000-00-00NoNoCurrent