fluticasone propionate and salmeterol hfa

Generic: fluticasone propionate and salmeterol xinafoate

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

Drug Facts

Product Profile

Brand Name fluticasone propionate and salmeterol hfa
Generic Name fluticasone propionate and salmeterol xinafoate
Labeler prasco laboratories
Dosage Form AEROSOL, METERED
Routes
RESPIRATORY (INHALATION)
Active Ingredients

fluticasone propionate 230 ug/1, salmeterol xinafoate 21 ug/1

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-088
Product ID 66993-088_8036f480-a038-4797-afdb-4b1e631eacd8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021254
Listing Expiration 2026-12-31
Marketing Start 2023-03-01

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 66993088
Hyphenated Format 66993-088

Supplemental Identifiers

RxCUI
896236 896244 896272
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 hfa (source: ndc)
Generic Name fluticasone propionate and salmeterol xinafoate (source: ndc)
Application Number NDA021254 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 230 ug/1
  • 21 ug/1
source: ndc
Packaging
  • 1 INHALER in 1 CARTON (66993-088-96) / 120 AEROSOL, METERED in 1 INHALER
source: ndc

Packages (1)

66993-088-96 1 INHALER in 1 CARTON (66993-088-96) / 120 AEROSOL, METERED in 1 INHALER

Ingredients (2)

fluticasone propionate (230 ug/1) salmeterol xinafoate (21 ug/1)

Linked Drug Pages (1)

Fluticasone Propionate and Salmeterol HFA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "8036f480-a038-4797-afdb-4b1e631eacd8", "openfda": {"unii": ["6EW8Q962A5", "O2GMZ0LF5W"], "rxcui": ["896236", "896244", "896272"], "spl_set_id": ["666c5b12-a4f7-4c53-8261-4742b5e5a6df"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INHALER in 1 CARTON (66993-088-96)  / 120 AEROSOL, METERED in 1 INHALER", "package_ndc": "66993-088-96", "marketing_start_date": "20230301"}], "brand_name": "Fluticasone Propionate and Salmeterol HFA", "product_id": "66993-088_8036f480-a038-4797-afdb-4b1e631eacd8", "dosage_form": "AEROSOL, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "66993-088", "generic_name": "fluticasone propionate and salmeterol xinafoate", "labeler_name": "Prasco Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluticasone Propionate and Salmeterol HFA", "active_ingredients": [{"name": "FLUTICASONE PROPIONATE", "strength": "230 ug/1"}, {"name": "SALMETEROL XINAFOATE", "strength": "21 ug/1"}], "application_number": "NDA021254", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230301", "listing_expiration_date": "20261231"}