fluticasone propionate and salmeterol diskus

Generic: fluticasone propionate and salmeterol

Labeler: prasco laboratories
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name fluticasone propionate and salmeterol diskus
Generic Name fluticasone propionate and salmeterol
Labeler prasco laboratories
Dosage Form POWDER
Routes
RESPIRATORY (INHALATION)
Active Ingredients

fluticasone propionate 250 ug/1, salmeterol xinafoate 50 ug/1

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-585
Product ID 66993-585_0318e892-0db1-4a82-a649-9e530a2d1d05
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021077
Listing Expiration 2026-12-31
Marketing Start 2019-02-08

Pharmacologic Class

Classes
adrenergic beta2-agonists [moa] corticosteroid hormone receptor agonists [moa] corticosteroid [epc] beta2-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66993585
Hyphenated Format 66993-585

Supplemental Identifiers

RxCUI
896184 896209 896228
UNII
6EW8Q962A5 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 and salmeterol diskus (source: ndc)
Generic Name fluticasone propionate and salmeterol (source: ndc)
Application Number NDA021077 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 250 ug/1
  • 50 ug/1
source: ndc
Packaging
  • 1 INHALER in 1 CARTON (66993-585-97) / 60 POWDER in 1 INHALER
source: ndc

Packages (1)

66993-585-97 1 INHALER in 1 CARTON (66993-585-97) / 60 POWDER in 1 INHALER

Ingredients (2)

fluticasone propionate (250 ug/1) salmeterol xinafoate (50 ug/1)

Linked Drug Pages (1)

Fluticasone Propionate and Salmeterol DISKUS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "0318e892-0db1-4a82-a649-9e530a2d1d05", "openfda": {"unii": ["6EW8Q962A5", "O2GMZ0LF5W"], "rxcui": ["896184", "896209", "896228"], "spl_set_id": ["6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INHALER in 1 CARTON (66993-585-97)  / 60 POWDER in 1 INHALER", "package_ndc": "66993-585-97", "marketing_start_date": "20190208"}], "brand_name": "Fluticasone Propionate and Salmeterol DISKUS", "product_id": "66993-585_0318e892-0db1-4a82-a649-9e530a2d1d05", "dosage_form": "POWDER", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "66993-585", "generic_name": "fluticasone propionate and salmeterol", "labeler_name": "Prasco Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluticasone Propionate and Salmeterol", "brand_name_suffix": "DISKUS", "active_ingredients": [{"name": "FLUTICASONE PROPIONATE", "strength": "250 ug/1"}, {"name": "SALMETEROL XINAFOATE", "strength": "50 ug/1"}], "application_number": "NDA021077", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190208", "listing_expiration_date": "20261231"}