fluticasone propionate and salmeterol

Generic: fluticasone propionate and salmeterol

Labeler: preferred pharmaceuticals 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 preferred pharmaceuticals inc.
Dosage Form POWDER
Routes
RESPIRATORY (INHALATION)
Active Ingredients

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

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8453
Product ID 68788-8453_2ad7b10a-e9c2-4a64-bea5-f939b62e4f03
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203433
Listing Expiration 2026-12-31
Marketing Start 2023-05-30

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 687888453
Hyphenated Format 68788-8453

Supplemental Identifiers

RxCUI
896209
UNII
O2GMZ0LF5W 6EW8Q962A5

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 ANDA203433 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 250 ug/1
  • 50 ug/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (68788-8453-6) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER
source: ndc

Packages (1)

68788-8453-6 1 POUCH in 1 CARTON (68788-8453-6) / 1 INHALER in 1 POUCH / 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 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "2ad7b10a-e9c2-4a64-bea5-f939b62e4f03", "openfda": {"unii": ["O2GMZ0LF5W", "6EW8Q962A5"], "rxcui": ["896209"], "spl_set_id": ["0dea4818-e9d6-42f2-a702-90419fff2695"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (68788-8453-6)  / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER", "package_ndc": "68788-8453-6", "marketing_start_date": "20230530"}], "brand_name": "fluticasone propionate and salmeterol", "product_id": "68788-8453_2ad7b10a-e9c2-4a64-bea5-f939b62e4f03", "dosage_form": "POWDER", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "68788-8453", "generic_name": "fluticasone propionate and salmeterol", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fluticasone propionate and salmeterol", "active_ingredients": [{"name": "FLUTICASONE PROPIONATE", "strength": "250 ug/1"}, {"name": "SALMETEROL XINAFOATE", "strength": "50 ug/1"}], "application_number": "ANDA203433", "marketing_category": "ANDA", "marketing_start_date": "20230530", "listing_expiration_date": "20261231"}