fluocinonide

Generic: fluocinonide

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

Drug Facts

Product Profile

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

fluocinonide 1 mg/g

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-505
Product ID 68462-505_9c6c8ea8-4836-4bb8-882b-2375184485d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091282
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 68462505
Hyphenated Format 68462-505

Supplemental Identifiers

RxCUI
485647
UPC
0368462505656
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 ANDA091282 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 30 g in 1 TUBE (68462-505-35)
  • 60 g in 1 TUBE (68462-505-65)
  • 120 g in 1 TUBE (68462-505-66)
source: ndc

Packages (3)

68462-505-35 30 g in 1 TUBE (68462-505-35) 68462-505-65 60 g in 1 TUBE (68462-505-65) 68462-505-66 120 g in 1 TUBE (68462-505-66)

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": "9c6c8ea8-4836-4bb8-882b-2375184485d2", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0368462505656"], "unii": ["2W4A77YPAN"], "rxcui": ["485647"], "spl_set_id": ["50f1c216-78c6-4b93-b732-b3beeb78bd62"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 g in 1 TUBE (68462-505-35)", "package_ndc": "68462-505-35", "marketing_start_date": "20140714"}, {"sample": false, "description": "60 g in 1 TUBE (68462-505-65)", "package_ndc": "68462-505-65", "marketing_start_date": "20140714"}, {"sample": false, "description": "120 g in 1 TUBE (68462-505-66)", "package_ndc": "68462-505-66", "marketing_start_date": "20140714"}], "brand_name": "Fluocinonide", "product_id": "68462-505_9c6c8ea8-4836-4bb8-882b-2375184485d2", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68462-505", "generic_name": "Fluocinonide", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinonide", "active_ingredients": [{"name": "FLUOCINONIDE", "strength": "1 mg/g"}], "application_number": "ANDA091282", "marketing_category": "ANDA", "marketing_start_date": "20140714", "listing_expiration_date": "20261231"}