fluticasone propionate

Generic: fluticasone propionate

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluticasone propionate
Generic Name fluticasone propionate
Labeler cosette pharmaceuticals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluticasone propionate .5 mg/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0631
Product ID 0713-0631_de485a69-2992-143b-e053-2a95a90a4b89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077055
Listing Expiration 2026-12-31
Marketing Start 2006-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130631
Hyphenated Format 0713-0631

Supplemental Identifiers

RxCUI
895987
UPC
0307130631150 0307130631310 0307130631600
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 ANDA077055 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0713-0631-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0713-0631-31) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0713-0631-60) / 60 g in 1 TUBE
source: ndc

Packages (3)

0713-0631-15 1 TUBE in 1 CARTON (0713-0631-15) / 15 g in 1 TUBE 0713-0631-31 1 TUBE in 1 CARTON (0713-0631-31) / 30 g in 1 TUBE 0713-0631-60 1 TUBE in 1 CARTON (0713-0631-60) / 60 g in 1 TUBE

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": "de485a69-2992-143b-e053-2a95a90a4b89", "openfda": {"upc": ["0307130631150", "0307130631310", "0307130631600"], "unii": ["O2GMZ0LF5W"], "rxcui": ["895987"], "spl_set_id": ["14c8d082-b301-8f09-a509-950459ae0a28"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0713-0631-15)  / 15 g in 1 TUBE", "package_ndc": "0713-0631-15", "marketing_start_date": "20060630"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0713-0631-31)  / 30 g in 1 TUBE", "package_ndc": "0713-0631-31", "marketing_start_date": "20060630"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0713-0631-60)  / 60 g in 1 TUBE", "package_ndc": "0713-0631-60", "marketing_start_date": "20060630"}], "brand_name": "Fluticasone Propionate", "product_id": "0713-0631_de485a69-2992-143b-e053-2a95a90a4b89", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0713-0631", "generic_name": "Fluticasone Propionate", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluticasone Propionate", "active_ingredients": [{"name": "FLUTICASONE PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA077055", "marketing_category": "ANDA", "marketing_start_date": "20060630", "listing_expiration_date": "20261231"}