fluocinonide cream

Generic: fluocinonide

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluocinonide cream
Generic Name fluocinonide
Labeler amneal pharmaceuticals ny llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluocinonide .5 mg/g

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1534
Product ID 69238-1534_64167760-d963-439f-ac85-21eefb5e8b39
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210554
Listing Expiration 2026-12-31
Marketing Start 2017-10-01

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 692381534
Hyphenated Format 69238-1534

Supplemental Identifiers

RxCUI
103456
UPC
0369238153439
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 cream (source: ndc)
Generic Name fluocinonide (source: ndc)
Application Number ANDA210554 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (69238-1534-2) / 120 g in 1 TUBE
  • 1 TUBE in 1 CARTON (69238-1534-3) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (69238-1534-5) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (69238-1534-6) / 60 g in 1 TUBE
source: ndc

Packages (4)

69238-1534-2 1 TUBE in 1 CARTON (69238-1534-2) / 120 g in 1 TUBE 69238-1534-3 1 TUBE in 1 CARTON (69238-1534-3) / 30 g in 1 TUBE 69238-1534-5 1 TUBE in 1 CARTON (69238-1534-5) / 15 g in 1 TUBE 69238-1534-6 1 TUBE in 1 CARTON (69238-1534-6) / 60 g in 1 TUBE

Ingredients (1)

fluocinonide (.5 mg/g)

Linked Drug Pages (1)

Fluocinonide Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "64167760-d963-439f-ac85-21eefb5e8b39", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0369238153439"], "unii": ["2W4A77YPAN"], "rxcui": ["103456"], "spl_set_id": ["817cac6b-fec5-406d-aa0c-8852d08a3c65"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (69238-1534-2)  / 120 g in 1 TUBE", "package_ndc": "69238-1534-2", "marketing_start_date": "20171001"}, {"sample": false, "description": "1 TUBE in 1 CARTON (69238-1534-3)  / 30 g in 1 TUBE", "package_ndc": "69238-1534-3", "marketing_start_date": "20171001"}, {"sample": false, "description": "1 TUBE in 1 CARTON (69238-1534-5)  / 15 g in 1 TUBE", "package_ndc": "69238-1534-5", "marketing_start_date": "20171001"}, {"sample": false, "description": "1 TUBE in 1 CARTON (69238-1534-6)  / 60 g in 1 TUBE", "package_ndc": "69238-1534-6", "marketing_start_date": "20171001"}], "brand_name": "Fluocinonide Cream", "product_id": "69238-1534_64167760-d963-439f-ac85-21eefb5e8b39", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "69238-1534", "generic_name": "Fluocinonide", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluocinonide Cream", "active_ingredients": [{"name": "FLUOCINONIDE", "strength": ".5 mg/g"}], "application_number": "ANDA210554", "marketing_category": "ANDA", "marketing_start_date": "20171001", "listing_expiration_date": "20261231"}