fluticasone propionate

Generic: fluticasone propionate

Labeler: e. fougera & co. a division of fougera pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluticasone propionate
Generic Name fluticasone propionate
Labeler e. fougera & co. a division of fougera pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluticasone propionate .5 mg/g

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0168-0332
Product ID 0168-0332_c1a3e651-d30b-49d5-8c5b-77a07006194f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076451
Listing Expiration 2026-12-31
Marketing Start 2004-05-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01680332
Hyphenated Format 0168-0332

Supplemental Identifiers

RxCUI
895987
UPC
0301680332154
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 ANDA076451 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 15 g in 1 TUBE (0168-0332-15)
  • 30 g in 1 TUBE (0168-0332-30)
  • 60 g in 1 TUBE (0168-0332-60)
source: ndc

Packages (3)

0168-0332-15 15 g in 1 TUBE (0168-0332-15) 0168-0332-30 30 g in 1 TUBE (0168-0332-30) 0168-0332-60 60 g in 1 TUBE (0168-0332-60)

Ingredients (1)

fluticasone propionate (.5 mg/g)

Linked Drug Pages (1)

FLUTICASONE PROPIONATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "c1a3e651-d30b-49d5-8c5b-77a07006194f", "openfda": {"upc": ["0301680332154"], "unii": ["O2GMZ0LF5W"], "rxcui": ["895987"], "spl_set_id": ["0e20d1cc-5c7a-4e0d-810b-b94c4d6dd1c0"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (0168-0332-15)", "package_ndc": "0168-0332-15", "marketing_start_date": "20040514"}, {"sample": false, "description": "30 g in 1 TUBE (0168-0332-30)", "package_ndc": "0168-0332-30", "marketing_start_date": "20040514"}, {"sample": false, "description": "60 g in 1 TUBE (0168-0332-60)", "package_ndc": "0168-0332-60", "marketing_start_date": "20040514"}], "brand_name": "FLUTICASONE PROPIONATE", "product_id": "0168-0332_c1a3e651-d30b-49d5-8c5b-77a07006194f", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0168-0332", "generic_name": "fluticasone propionate", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUTICASONE PROPIONATE", "active_ingredients": [{"name": "FLUTICASONE PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA076451", "marketing_category": "ANDA", "marketing_start_date": "20040514", "listing_expiration_date": "20261231"}