fluticasone propionate and salmeterol

Generic: fluticasone propionate and salmeterol

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluticasone propionate and salmeterol
Generic Name fluticasone propionate and salmeterol
Labeler lannett company, inc.
Dosage Form POWDER
Routes
RESPIRATORY (INHALATION)
Active Ingredients

fluticasone propionate 100 ug/1, salmeterol xinafoate 50 ug/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-6010
Product ID 0527-6010_efbe29ce-a9b0-4b50-85df-780d8050315c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214464
Listing Expiration 2027-12-31
Marketing Start 2026-01-12

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 05276010
Hyphenated Format 0527-6010

Supplemental Identifiers

RxCUI
896184 896209
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 (source: ndc)
Generic Name fluticasone propionate and salmeterol (source: ndc)
Application Number ANDA214464 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 100 ug/1
  • 50 ug/1
source: ndc
Packaging
  • 1 INHALER in 1 CARTON (0527-6010-06) / 60 POWDER in 1 INHALER
source: ndc

Packages (1)

0527-6010-06 1 INHALER in 1 CARTON (0527-6010-06) / 60 POWDER in 1 INHALER

Ingredients (2)

fluticasone propionate (100 ug/1) salmeterol xinafoate (50 ug/1)

Linked Drug Pages (1)

Fluticasone Propionate and Salmeterol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "efbe29ce-a9b0-4b50-85df-780d8050315c", "openfda": {"unii": ["6EW8Q962A5", "O2GMZ0LF5W"], "rxcui": ["896184", "896209"], "spl_set_id": ["9c1680db-16e9-4658-977b-110631f95a65"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INHALER in 1 CARTON (0527-6010-06)  / 60 POWDER in 1 INHALER", "package_ndc": "0527-6010-06", "marketing_start_date": "20260112"}], "brand_name": "Fluticasone Propionate and Salmeterol", "product_id": "0527-6010_efbe29ce-a9b0-4b50-85df-780d8050315c", "dosage_form": "POWDER", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0527-6010", "generic_name": "fluticasone propionate and salmeterol", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluticasone Propionate and Salmeterol", "active_ingredients": [{"name": "FLUTICASONE PROPIONATE", "strength": "100 ug/1"}, {"name": "SALMETEROL XINAFOATE", "strength": "50 ug/1"}], "application_number": "ANDA214464", "marketing_category": "ANDA", "marketing_start_date": "20260112", "listing_expiration_date": "20271231"}