fluticasone propionate

Generic: fluticasone propionate

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluticasone propionate
Generic Name fluticasone propionate
Labeler padagis israel pharmaceuticals ltd
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

fluticasone propionate .5 mg/mL

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-441
Product ID 45802-441_8a4c8510-ac39-4d97-b713-7581de6a8f0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091553
Listing Expiration 2026-12-31
Marketing Start 2013-08-08

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802441
Hyphenated Format 45802-441

Supplemental Identifiers

RxCUI
895990
UNII
O2GMZ0LF5W

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 fluticasone propionate (source: ndc)
Generic Name fluticasone propionate (source: ndc)
Application Number ANDA091553 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 60 mL in 1 BOTTLE (45802-441-02)
source: ndc

Packages (1)

45802-441-02 60 mL in 1 BOTTLE (45802-441-02)

Ingredients (1)

fluticasone propionate (.5 mg/mL)

Linked Drug Pages (1)

fluticasone propionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "8a4c8510-ac39-4d97-b713-7581de6a8f0a", "openfda": {"unii": ["O2GMZ0LF5W"], "rxcui": ["895990"], "spl_set_id": ["c4d361d4-d480-4fb2-8cc7-4cc3e57838dc"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 mL in 1 BOTTLE (45802-441-02)", "package_ndc": "45802-441-02", "marketing_start_date": "20130808"}], "brand_name": "fluticasone propionate", "product_id": "45802-441_8a4c8510-ac39-4d97-b713-7581de6a8f0a", "dosage_form": "LOTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "45802-441", "generic_name": "fluticasone propionate", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fluticasone propionate", "active_ingredients": [{"name": "FLUTICASONE PROPIONATE", "strength": ".5 mg/mL"}], "application_number": "ANDA091553", "marketing_category": "ANDA", "marketing_start_date": "20130808", "listing_expiration_date": "20261231"}