fluocinonide

Generic: fluocinonide

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluocinonide
Generic Name fluocinonide
Labeler preferred pharmaceuticals inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

fluocinonide .5 mg/g

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8554
Product ID 68788-8554_6fb899dd-d30f-4391-9c79-cf79d4aec06f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075008
Listing Expiration 2026-12-31
Marketing Start 2023-11-20

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 687888554
Hyphenated Format 68788-8554

Supplemental Identifiers

RxCUI
103457
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 ANDA075008 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68788-8554-6) / 60 g in 1 TUBE
source: ndc

Packages (1)

68788-8554-6 1 TUBE in 1 CARTON (68788-8554-6) / 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": "6fb899dd-d30f-4391-9c79-cf79d4aec06f", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["2W4A77YPAN"], "rxcui": ["103457"], "spl_set_id": ["80b72854-3fae-4cc7-bc41-2bdeb3e2cbe1"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68788-8554-6)  / 60 g in 1 TUBE", "package_ndc": "68788-8554-6", "marketing_start_date": "20231120"}], "brand_name": "Fluocinonide", "product_id": "68788-8554_6fb899dd-d30f-4391-9c79-cf79d4aec06f", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68788-8554", "generic_name": "Fluocinonide", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinonide", "active_ingredients": [{"name": "FLUOCINONIDE", "strength": ".5 mg/g"}], "application_number": "ANDA075008", "marketing_category": "ANDA", "marketing_start_date": "20231120", "listing_expiration_date": "20261231"}