ak-fluor

Generic: fluorescein

Labeler: long grove pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ak-fluor
Generic Name fluorescein
Labeler long grove pharmaceuticals, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fluorescein sodium 100 mg/mL

Manufacturer
Long Grove Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 81298-8660
Product ID 81298-8660_63320a27-e723-4b3b-9210-3f2e67444870
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022186
Listing Expiration 2026-12-31
Marketing Start 2024-09-28

Pharmacologic Class

Classes
diagnostic dye [epc] dyes [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 812988660
Hyphenated Format 81298-8660

Supplemental Identifiers

UPC
0381298866036
UNII
93X55PE38X

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 ak-fluor (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 VIAL, GLASS in 1 CARTON (81298-8660-3) / 5 mL in 1 VIAL, GLASS (81298-8660-1)
source: ndc

Packages (1)

81298-8660-3 12 VIAL, GLASS in 1 CARTON (81298-8660-3) / 5 mL in 1 VIAL, GLASS (81298-8660-1)

Ingredients (1)

fluorescein sodium (100 mg/mL)

Linked Drug Pages (1)

AK-FLUOR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "63320a27-e723-4b3b-9210-3f2e67444870", "openfda": {"upc": ["0381298866036"], "unii": ["93X55PE38X"], "spl_set_id": ["73511e79-c050-4dc0-aa2f-a79ed320b5b0"], "manufacturer_name": ["Long Grove Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 VIAL, GLASS in 1 CARTON (81298-8660-3)  / 5 mL in 1 VIAL, GLASS (81298-8660-1)", "package_ndc": "81298-8660-3", "marketing_start_date": "20240928"}], "brand_name": "AK-FLUOR", "product_id": "81298-8660_63320a27-e723-4b3b-9210-3f2e67444870", "dosage_form": "INJECTION", "pharm_class": ["Diagnostic Dye [EPC]", "Dyes [MoA]"], "product_ndc": "81298-8660", "generic_name": "fluorescein", "labeler_name": "Long Grove Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AK-FLUOR", "active_ingredients": [{"name": "FLUORESCEIN SODIUM", "strength": "100 mg/mL"}], "application_number": "NDA022186", "marketing_category": "NDA", "marketing_start_date": "20240928", "listing_expiration_date": "20261231"}