fluocinonide

Generic: fluocinonide

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

Drug Facts

Product Profile

Brand Name fluocinonide
Generic Name fluocinonide
Labeler zydus pharmaceuticals usa inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

fluocinonide .5 mg/mL

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1284
Product ID 70710-1284_bd0eaa0d-0a5b-48a2-bc7e-78b8bde33962
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208948
Listing Expiration 2026-12-31
Marketing Start 2018-11-01

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 707101284
Hyphenated Format 70710-1284

Supplemental Identifiers

RxCUI
310364
UPC
0370710128432
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 ANDA208948 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 60 mL in 1 BOTTLE (70710-1284-3)
  • 20 mL in 1 BOTTLE (70710-1284-8)
source: ndc

Packages (2)

70710-1284-3 60 mL in 1 BOTTLE (70710-1284-3) 70710-1284-8 20 mL in 1 BOTTLE (70710-1284-8)

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": "bd0eaa0d-0a5b-48a2-bc7e-78b8bde33962", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0370710128432"], "unii": ["2W4A77YPAN"], "rxcui": ["310364"], "spl_set_id": ["73315c87-4e55-41ea-883b-23d504c1b10d"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 mL in 1 BOTTLE (70710-1284-3)", "package_ndc": "70710-1284-3", "marketing_start_date": "20181101"}, {"sample": false, "description": "20 mL in 1 BOTTLE (70710-1284-8)", "package_ndc": "70710-1284-8", "marketing_start_date": "20181101"}], "brand_name": "Fluocinonide", "product_id": "70710-1284_bd0eaa0d-0a5b-48a2-bc7e-78b8bde33962", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70710-1284", "generic_name": "Fluocinonide", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinonide", "active_ingredients": [{"name": "FLUOCINONIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA208948", "marketing_category": "ANDA", "marketing_start_date": "20181101", "listing_expiration_date": "20261231"}