fluocinonide

Generic: fluocinonide

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

Drug Facts

Product Profile

Brand Name fluocinonide
Generic Name fluocinonide
Labeler cosette pharmaceuticals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluocinonide .5 mg/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0663
Product ID 0713-0663_f0d2ff2b-732c-ae99-e053-2995a90a1ee7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073085
Listing Expiration 2026-12-31
Marketing Start 2022-11-16

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 07130663
Hyphenated Format 0713-0663

Supplemental Identifiers

RxCUI
103456
UPC
0307130663311 0307130663151
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 ANDA073085 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0713-0663-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0713-0663-31) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0713-0663-60) / 60 g in 1 TUBE
source: ndc

Packages (3)

0713-0663-15 1 TUBE in 1 CARTON (0713-0663-15) / 15 g in 1 TUBE 0713-0663-31 1 TUBE in 1 CARTON (0713-0663-31) / 30 g in 1 TUBE 0713-0663-60 1 TUBE in 1 CARTON (0713-0663-60) / 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": "f0d2ff2b-732c-ae99-e053-2995a90a1ee7", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0307130663311", "0307130663151"], "unii": ["2W4A77YPAN"], "rxcui": ["103456"], "spl_set_id": ["e3348b90-8c16-4788-ab61-e354aea5d0a8"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0713-0663-15)  / 15 g in 1 TUBE", "package_ndc": "0713-0663-15", "marketing_start_date": "20221116"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0713-0663-31)  / 30 g in 1 TUBE", "package_ndc": "0713-0663-31", "marketing_start_date": "20221116"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0713-0663-60)  / 60 g in 1 TUBE", "package_ndc": "0713-0663-60", "marketing_start_date": "20221116"}], "brand_name": "Fluocinonide", "product_id": "0713-0663_f0d2ff2b-732c-ae99-e053-2995a90a1ee7", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0713-0663", "generic_name": "Fluocinonide", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinonide", "active_ingredients": [{"name": "FLUOCINONIDE", "strength": ".5 mg/g"}], "application_number": "ANDA073085", "marketing_category": "ANDA", "marketing_start_date": "20221116", "listing_expiration_date": "20261231"}