azelastine hydrochloride and fluticasone propionate

Generic: azelastine hydrochloride and fluticasone propionate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hydrochloride and fluticasone propionate
Generic Name azelastine hydrochloride and fluticasone propionate
Labeler mylan pharmaceuticals inc.
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

azelastine hydrochloride 137 ug/1, fluticasone propionate 50 ug/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-3458
Product ID 0378-3458_6e1e173a-2d01-4e67-8361-dd30604bc8aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA202236
Marketing Start 2020-04-14
Marketing End 2027-02-28

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03783458
Hyphenated Format 0378-3458

Supplemental Identifiers

RxCUI
1797847
UNII
0L591QR10I 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 azelastine hydrochloride and fluticasone propionate (source: ndc)
Generic Name azelastine hydrochloride and fluticasone propionate (source: ndc)
Application Number NDA202236 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 137 ug/1
  • 50 ug/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (0378-3458-23) / 120 SPRAY, METERED in 1 BOTTLE
source: ndc

Packages (1)

0378-3458-23 1 BOTTLE in 1 BOX (0378-3458-23) / 120 SPRAY, METERED in 1 BOTTLE

Ingredients (2)

azelastine hydrochloride (137 ug/1) fluticasone propionate (50 ug/1)

Linked Drug Pages (1)

Azelastine Hydrochloride and Fluticasone Propionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "6e1e173a-2d01-4e67-8361-dd30604bc8aa", "openfda": {"unii": ["0L591QR10I", "O2GMZ0LF5W"], "rxcui": ["1797847"], "spl_set_id": ["7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (0378-3458-23)  / 120 SPRAY, METERED in 1 BOTTLE", "package_ndc": "0378-3458-23", "marketing_end_date": "20270228", "marketing_start_date": "20200414"}], "brand_name": "Azelastine Hydrochloride and Fluticasone Propionate", "product_id": "0378-3458_6e1e173a-2d01-4e67-8361-dd30604bc8aa", "dosage_form": "SPRAY, METERED", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0378-3458", "generic_name": "Azelastine Hydrochloride and Fluticasone Propionate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azelastine Hydrochloride and Fluticasone Propionate", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": "137 ug/1"}, {"name": "FLUTICASONE PROPIONATE", "strength": "50 ug/1"}], "application_number": "NDA202236", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20270228", "marketing_start_date": "20200414"}