fluocinonide

Generic: fluocinonide

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluocinonide
Generic Name fluocinonide
Labeler padagis israel pharmaceuticals ltd
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

fluocinonide .5 mg/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-761
Product ID 45802-761_9f42e872-a537-4ef0-85f0-7c5e0445a92a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209030
Listing Expiration 2026-12-31
Marketing Start 2025-04-10

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802761
Hyphenated Format 45802-761

Supplemental Identifiers

RxCUI
310362
UNII
2W4A77YPAN
NUI
N0000175576 N0000175450

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 fluocinonide (source: ndc)
Generic Name fluocinonide (source: ndc)
Application Number ANDA209030 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (45802-761-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-761-30) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-761-60) / 60 g in 1 TUBE
source: ndc

Packages (3)

45802-761-15 1 TUBE in 1 CARTON (45802-761-15) / 15 g in 1 TUBE 45802-761-30 1 TUBE in 1 CARTON (45802-761-30) / 30 g in 1 TUBE 45802-761-60 1 TUBE in 1 CARTON (45802-761-60) / 60 g in 1 TUBE

Ingredients (1)

fluocinonide (.5 mg/g)

Linked Drug Pages (1)

FLUOCINONIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "9f42e872-a537-4ef0-85f0-7c5e0445a92a", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["2W4A77YPAN"], "rxcui": ["310362"], "spl_set_id": ["8e22600e-a1a2-432c-a47c-b7b99a0b1e46"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-761-15)  / 15 g in 1 TUBE", "package_ndc": "45802-761-15", "marketing_start_date": "20250410"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-761-30)  / 30 g in 1 TUBE", "package_ndc": "45802-761-30", "marketing_start_date": "20250410"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-761-60)  / 60 g in 1 TUBE", "package_ndc": "45802-761-60", "marketing_start_date": "20250410"}], "brand_name": "FLUOCINONIDE", "product_id": "45802-761_9f42e872-a537-4ef0-85f0-7c5e0445a92a", "dosage_form": "GEL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "45802-761", "generic_name": "fluocinonide", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOCINONIDE", "active_ingredients": [{"name": "FLUOCINONIDE", "strength": ".5 mg/g"}], "application_number": "ANDA209030", "marketing_category": "ANDA", "marketing_start_date": "20250410", "listing_expiration_date": "20261231"}