fluticasone propionate and salmeterol (0054-0326)

Drug Facts

Product Profile

Brand Name fluticasone propionate and salmeterol

Generic Name fluticasone propionate and salmeterol

Labeler hikma pharmaceuticals usa inc.

Dosage Form POWDER

Routes

RESPIRATORY (INHALATION)

Active Ingredients

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

Manufacturer

Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0326

Product ID 0054-0326_e2206df8-d8d5-4bef-beff-e70c42419d01

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA203433

Listing Expiration 2026-12-31

Marketing Start 2020-12-17

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 00540326

Hyphenated Format 0054-0326

Supplemental Identifiers

RxCUI

896184 896209 896228

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 ANDA203433 (source: ndc)

Routes

RESPIRATORY (INHALATION)

source: ndc

Resolved Composition

Strengths

100 ug/1
50 ug/1

source: ndc

Packaging

1 POUCH in 1 CARTON (0054-0326-56) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER

source: ndc

Packages (1)

0054-0326-56 1 POUCH in 1 CARTON (0054-0326-56) / 1 INHALER in 1 POUCH / 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": "e2206df8-d8d5-4bef-beff-e70c42419d01", "openfda": {"unii": ["6EW8Q962A5", "O2GMZ0LF5W"], "rxcui": ["896184", "896209", "896228"], "spl_set_id": ["f9fcfc90-3677-4a9b-900e-44417d50d507"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (0054-0326-56)  / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER", "package_ndc": "0054-0326-56", "marketing_start_date": "20201217"}], "brand_name": "fluticasone propionate and salmeterol", "product_id": "0054-0326_e2206df8-d8d5-4bef-beff-e70c42419d01", "dosage_form": "POWDER", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0054-0326", "generic_name": "fluticasone propionate and salmeterol", "labeler_name": "Hikma Pharmaceuticals USA 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": "ANDA203433", "marketing_category": "ANDA", "marketing_start_date": "20201217", "listing_expiration_date": "20261231"}