fluticasone propionate and salmeterol

Generic: fluticasone propionate and salmeterol

Labeler: teva pharmaceuticals usa, inc.
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 teva pharmaceuticals usa, inc.
Dosage Form POWDER, METERED
Routes
RESPIRATORY (INHALATION)
Active Ingredients

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

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-3607
Product ID 0093-3607_f09e7a41-3e53-48b2-ab31-a249f4fb28ca
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 00933607
Hyphenated Format 0093-3607

Supplemental Identifiers

RxCUI
1918194 1918203 1918209
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 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 (0093-3607-82) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
source: ndc

Packages (1)

0093-3607-82 1 POUCH in 1 CARTON (0093-3607-82) / 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": "f09e7a41-3e53-48b2-ab31-a249f4fb28ca", "openfda": {"unii": ["6EW8Q962A5", "O2GMZ0LF5W"], "rxcui": ["1918194", "1918203", "1918209"], "spl_set_id": ["43a27267-2f2b-410d-9c30-9cb95f35d9a1"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (0093-3607-82)  / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER", "package_ndc": "0093-3607-82", "marketing_start_date": "20170428"}], "brand_name": "Fluticasone Propionate and Salmeterol", "product_id": "0093-3607_f09e7a41-3e53-48b2-ab31-a249f4fb28ca", "dosage_form": "POWDER, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0093-3607", "generic_name": "Fluticasone Propionate and Salmeterol", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "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"}