fluocinonide

Generic: fluocinonide

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluocinonide
Generic Name fluocinonide
Labeler sun pharmaceutical industries, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluocinonide 1 mg/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1353
Product ID 51672-1353_390c3bf3-dd9d-f100-e063-6294a90a81f1
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 516721353
Hyphenated Format 51672-1353

Supplemental Identifiers

RxCUI
485647
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 ANDA200734 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51672-1353-2) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-1353-3) / 60 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-1353-4) / 120 g in 1 TUBE
source: ndc

Packages (3)

51672-1353-2 1 TUBE in 1 CARTON (51672-1353-2) / 30 g in 1 TUBE 51672-1353-3 1 TUBE in 1 CARTON (51672-1353-3) / 60 g in 1 TUBE 51672-1353-4 1 TUBE in 1 CARTON (51672-1353-4) / 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": "390c3bf3-dd9d-f100-e063-6294a90a81f1", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["2W4A77YPAN"], "rxcui": ["485647"], "spl_set_id": ["16c7d142-e695-4e33-986f-78cb37f7b387"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-1353-2)  / 30 g in 1 TUBE", "package_ndc": "51672-1353-2", "marketing_start_date": "20140714"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-1353-3)  / 60 g in 1 TUBE", "package_ndc": "51672-1353-3", "marketing_start_date": "20140714"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-1353-4)  / 120 g in 1 TUBE", "package_ndc": "51672-1353-4", "marketing_start_date": "20140714"}], "brand_name": "Fluocinonide", "product_id": "51672-1353_390c3bf3-dd9d-f100-e063-6294a90a81f1", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "51672-1353", "generic_name": "Fluocinonide", "labeler_name": "Sun Pharmaceutical Industries, 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"}