fluticasone propionate and salmeterol

Generic: fluticasone propionate and salmeterol

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name fluticasone propionate and salmeterol
Generic Name fluticasone propionate and salmeterol
Labeler bryant ranch prepack
Dosage Form POWDER, METERED
Routes
RESPIRATORY (INHALATION)
Active Ingredients

fluticasone propionate 55 ug/1, salmeterol xinafoate 14 ug/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8811
Product ID 63629-8811_b6d73632-205b-4d93-bc38-f520fd6c189b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA208799
Listing Expiration 2026-12-31
Marketing Start 2017-04-28

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 636298811
Hyphenated Format 63629-8811

Supplemental Identifiers

RxCUI
1918209
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 NDA208799 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 55 ug/1
  • 14 ug/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (63629-8811-1) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
source: ndc

Packages (1)

63629-8811-1 1 POUCH in 1 CARTON (63629-8811-1) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER

Ingredients (2)

fluticasone propionate (55 ug/1) salmeterol xinafoate (14 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": "b6d73632-205b-4d93-bc38-f520fd6c189b", "openfda": {"unii": ["O2GMZ0LF5W", "6EW8Q962A5"], "rxcui": ["1918209"], "spl_set_id": ["038db4da-1448-4603-a34d-2efd9059811b"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (63629-8811-1)  / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER", "package_ndc": "63629-8811-1", "marketing_start_date": "20170428"}], "brand_name": "Fluticasone Propionate and Salmeterol", "product_id": "63629-8811_b6d73632-205b-4d93-bc38-f520fd6c189b", "dosage_form": "POWDER, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "63629-8811", "generic_name": "Fluticasone Propionate and Salmeterol", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluticasone Propionate and Salmeterol", "active_ingredients": [{"name": "FLUTICASONE PROPIONATE", "strength": "55 ug/1"}, {"name": "SALMETEROL XINAFOATE", "strength": "14 ug/1"}], "application_number": "NDA208799", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20170428", "listing_expiration_date": "20261231"}