fluocinonide

Generic: fluocinonide topical solution usp, 0.05%

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

Drug Facts

Product Profile

Brand Name fluocinonide
Generic Name fluocinonide topical solution usp, 0.05%
Labeler encube ethicals, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

fluocinonide .5 mg/mL

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-001
Product ID 21922-001_85d64cb1-93f5-480d-b454-ca43810c8539
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209699
Listing Expiration 2027-12-31
Marketing Start 2019-04-19

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 21922001
Hyphenated Format 21922-001

Supplemental Identifiers

RxCUI
310364
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 topical solution usp, 0.05% (source: ndc)
Application Number ANDA209699 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (21922-001-01) / 60 mL in 1 BOTTLE
source: ndc

Packages (1)

21922-001-01 1 BOTTLE in 1 CARTON (21922-001-01) / 60 mL in 1 BOTTLE

Ingredients (1)

fluocinonide (.5 mg/mL)

Linked Drug Pages (1)

Fluocinonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "85d64cb1-93f5-480d-b454-ca43810c8539", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["2W4A77YPAN"], "rxcui": ["310364"], "spl_set_id": ["4b1f775e-a7ad-4151-975e-6026296b5cea"], "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 BOTTLE in 1 CARTON (21922-001-01)  / 60 mL in 1 BOTTLE", "package_ndc": "21922-001-01", "marketing_start_date": "20190419"}], "brand_name": "Fluocinonide", "product_id": "21922-001_85d64cb1-93f5-480d-b454-ca43810c8539", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "21922-001", "generic_name": "fluocinonide topical solution usp, 0.05%", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinonide", "active_ingredients": [{"name": "FLUOCINONIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA209699", "marketing_category": "ANDA", "marketing_start_date": "20190419", "listing_expiration_date": "20271231"}