wixela inhub

Generic: fluticasone propionate and salmeterol

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name wixela inhub
Generic Name fluticasone propionate and salmeterol
Labeler mylan pharmaceuticals inc.
Dosage Form POWDER
Routes
RESPIRATORY (INHALATION)
Active Ingredients

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

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-9321
Product ID 0378-9321_03d33612-03b4-4a2c-ba86-47816db363ce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208891
Listing Expiration 2026-12-31
Marketing Start 2019-02-11

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 03789321
Hyphenated Format 0378-9321

Supplemental Identifiers

RxCUI
896184 896209 896228 2110510 2110513 2110516
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 wixela inhub (source: ndc)
Generic Name fluticasone propionate and salmeterol (source: ndc)
Application Number ANDA208891 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 250 ug/1
  • 50 ug/1
source: ndc
Packaging
  • 1 INHALER in 1 CARTON (0378-9321-32) / 60 POWDER in 1 INHALER
source: ndc

Packages (1)

0378-9321-32 1 INHALER in 1 CARTON (0378-9321-32) / 60 POWDER in 1 INHALER

Ingredients (2)

fluticasone propionate (250 ug/1) salmeterol xinafoate (50 ug/1)

Linked Drug Pages (1)

Wixela Inhub ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "03d33612-03b4-4a2c-ba86-47816db363ce", "openfda": {"unii": ["6EW8Q962A5", "O2GMZ0LF5W"], "rxcui": ["896184", "896209", "896228", "2110510", "2110513", "2110516"], "spl_set_id": ["3beef422-8a07-4a45-9ba6-414511e4b7e2"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INHALER in 1 CARTON (0378-9321-32)  / 60 POWDER in 1 INHALER", "package_ndc": "0378-9321-32", "marketing_start_date": "20190211"}], "brand_name": "Wixela Inhub", "product_id": "0378-9321_03d33612-03b4-4a2c-ba86-47816db363ce", "dosage_form": "POWDER", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0378-9321", "generic_name": "fluticasone propionate and salmeterol", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Wixela Inhub", "active_ingredients": [{"name": "FLUTICASONE PROPIONATE", "strength": "250 ug/1"}, {"name": "SALMETEROL XINAFOATE", "strength": "50 ug/1"}], "application_number": "ANDA208891", "marketing_category": "ANDA", "marketing_start_date": "20190211", "listing_expiration_date": "20261231"}