fluocinonide

Generic: fluocinonide

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluocinonide
Generic Name fluocinonide
Labeler encube ethicals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluocinonide .5 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-064
Product ID 21922-064_d17e15ec-9150-4fe3-acd1-4573300d9bf3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211410
Listing Expiration 2026-12-31
Marketing Start 2025-02-25

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 21922064
Hyphenated Format 21922-064

Supplemental Identifiers

RxCUI
103456
UPC
0321922064070 0321922064049 0321922064056 0321922064032
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 ANDA211410 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-064-03) / 120 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-064-04) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-064-05) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-064-07) / 60 g in 1 TUBE
source: ndc

Packages (4)

21922-064-03 1 TUBE in 1 CARTON (21922-064-03) / 120 g in 1 TUBE 21922-064-04 1 TUBE in 1 CARTON (21922-064-04) / 15 g in 1 TUBE 21922-064-05 1 TUBE in 1 CARTON (21922-064-05) / 30 g in 1 TUBE 21922-064-07 1 TUBE in 1 CARTON (21922-064-07) / 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": "d17e15ec-9150-4fe3-acd1-4573300d9bf3", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0321922064070", "0321922064049", "0321922064056", "0321922064032"], "unii": ["2W4A77YPAN"], "rxcui": ["103456"], "spl_set_id": ["cb869315-8011-485b-8992-1d73fb27e19e"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-064-03)  / 120 g in 1 TUBE", "package_ndc": "21922-064-03", "marketing_start_date": "20250917"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-064-04)  / 15 g in 1 TUBE", "package_ndc": "21922-064-04", "marketing_start_date": "20250917"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-064-05)  / 30 g in 1 TUBE", "package_ndc": "21922-064-05", "marketing_start_date": "20250225"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-064-07)  / 60 g in 1 TUBE", "package_ndc": "21922-064-07", "marketing_start_date": "20250225"}], "brand_name": "FLUOCINONIDE", "product_id": "21922-064_d17e15ec-9150-4fe3-acd1-4573300d9bf3", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "21922-064", "generic_name": "Fluocinonide", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOCINONIDE", "active_ingredients": [{"name": "FLUOCINONIDE", "strength": ".5 mg/g"}], "application_number": "ANDA211410", "marketing_category": "ANDA", "marketing_start_date": "20250225", "listing_expiration_date": "20261231"}