fluocinonide

Generic: fluocinonide

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluocinonide
Generic Name fluocinonide
Labeler asclemed usa, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluocinonide 1 mg/g

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-509
Product ID 76420-509_0cad6c91-0fe0-91c8-e063-6394a90a3fe8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200734
Listing Expiration 2026-12-31
Marketing Start 2014-07-14

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 76420509
Hyphenated Format 76420-509

Supplemental Identifiers

RxCUI
485647
UNII
2W4A77YPAN
NUI
N0000175576 N0000175450

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 ANDA200734 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (76420-509-12) / 120 g in 1 TUBE
source: ndc

Packages (1)

76420-509-12 1 TUBE in 1 CARTON (76420-509-12) / 120 g in 1 TUBE

Ingredients (1)

fluocinonide (1 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": "0cad6c91-0fe0-91c8-e063-6394a90a3fe8", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["2W4A77YPAN"], "rxcui": ["485647"], "spl_set_id": ["cd5d8268-77ff-41c0-8699-b583e52da30c"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (76420-509-12)  / 120 g in 1 TUBE", "package_ndc": "76420-509-12", "marketing_start_date": "20231216"}], "brand_name": "Fluocinonide", "product_id": "76420-509_0cad6c91-0fe0-91c8-e063-6394a90a3fe8", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "76420-509", "generic_name": "Fluocinonide", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinonide", "active_ingredients": [{"name": "FLUOCINONIDE", "strength": "1 mg/g"}], "application_number": "ANDA200734", "marketing_category": "ANDA", "marketing_start_date": "20140714", "listing_expiration_date": "20261231"}