fluorescein

Generic: fluorescein

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluorescein
Generic Name fluorescein
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fluorescein sodium 100 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1533
Product ID 51662-1533_c915cb71-f04b-2377-e053-2995a90a5d92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022186
Listing Expiration 2026-12-31
Marketing Start 2021-05-10

Pharmacologic Class

Classes
diagnostic dye [epc] dyes [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621533
Hyphenated Format 51662-1533

Supplemental Identifiers

UNII
93X55PE38X

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fluorescein (source: ndc)
Generic Name fluorescein (source: ndc)
Application Number NDA022186 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 12 POUCH in 1 BOX (51662-1533-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

51662-1533-3 12 POUCH in 1 BOX (51662-1533-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

fluorescein sodium (100 mg/mL)

Linked Drug Pages (1)

FLUORESCEIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c915cb71-f04b-2377-e053-2995a90a5d92", "openfda": {"unii": ["93X55PE38X"], "spl_set_id": ["c1ffe119-7fba-940f-e053-2a95a90a7a17"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 BOX (51662-1533-3)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "51662-1533-3", "marketing_start_date": "20210510"}], "brand_name": "FLUORESCEIN", "product_id": "51662-1533_c915cb71-f04b-2377-e053-2995a90a5d92", "dosage_form": "INJECTION", "pharm_class": ["Diagnostic Dye [EPC]", "Dyes [MoA]"], "product_ndc": "51662-1533", "generic_name": "FLUORESCEIN", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUORESCEIN", "active_ingredients": [{"name": "FLUORESCEIN SODIUM", "strength": "100 mg/mL"}], "application_number": "NDA022186", "marketing_category": "NDA", "marketing_start_date": "20210510", "listing_expiration_date": "20261231"}