fluorescein

Generic: fluorescein

Labeler: nexus pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluorescein
Generic Name fluorescein
Labeler nexus pharmaceuticals llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fluorescein 500 mg/mL

Manufacturer
Nexus Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 14789-122
Product ID 14789-122_b66b331e-c90a-48e0-9d9d-961c1cb5c9e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215709
Listing Expiration 2026-12-31
Marketing Start 2023-10-24

Pharmacologic Class

Established (EPC)
diagnostic dye [epc]
Mechanism of Action
dyes [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14789122
Hyphenated Format 14789-122

Supplemental Identifiers

UPC
0314789122052
UNII
TPY09G7XIR
NUI
N0000175536 N0000175533

Packaging Origin

Original Packager
true

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 ANDA215709 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (14789-122-05) / 5 mL in 1 VIAL (14789-122-07)
source: ndc

Packages (1)

14789-122-05 10 VIAL in 1 CARTON (14789-122-05) / 5 mL in 1 VIAL (14789-122-07)

Ingredients (1)

fluorescein (500 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": "b66b331e-c90a-48e0-9d9d-961c1cb5c9e2", "openfda": {"nui": ["N0000175536", "N0000175533"], "upc": ["0314789122052"], "unii": ["TPY09G7XIR"], "spl_set_id": ["0a2a65b1-dc88-445b-bfb7-53b2fd7bea2c"], "pharm_class_epc": ["Diagnostic Dye [EPC]"], "pharm_class_moa": ["Dyes [MoA]"], "manufacturer_name": ["Nexus Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (14789-122-05)  / 5 mL in 1 VIAL (14789-122-07)", "package_ndc": "14789-122-05", "marketing_start_date": "20231024"}], "brand_name": "Fluorescein", "product_id": "14789-122_b66b331e-c90a-48e0-9d9d-961c1cb5c9e2", "dosage_form": "INJECTION", "pharm_class": ["Diagnostic Dye [EPC]", "Dyes [MoA]"], "product_ndc": "14789-122", "generic_name": "Fluorescein", "labeler_name": "Nexus Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluorescein", "active_ingredients": [{"name": "FLUORESCEIN", "strength": "500 mg/mL"}], "application_number": "ANDA215709", "marketing_category": "ANDA", "marketing_start_date": "20231024", "listing_expiration_date": "20261231"}