azelastine hydrochloride and fluticasone propionate

Generic: azelastine hydrochloride and fluticasone propionate

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hydrochloride and fluticasone propionate
Generic Name azelastine hydrochloride and fluticasone propionate
Labeler apotex corp.
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

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

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0953
Product ID 60505-0953_2a316a42-19b9-2939-cda9-71111b40a4c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207712
Listing Expiration 2026-12-31
Marketing Start 2020-03-02

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 605050953
Hyphenated Format 60505-0953

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 ANDA207712 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 137 ug/1
  • 50 ug/1
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (60505-0953-3) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

60505-0953-3 1 BOTTLE, SPRAY in 1 CARTON (60505-0953-3) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

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": "2a316a42-19b9-2939-cda9-71111b40a4c4", "openfda": {"unii": ["0L591QR10I", "O2GMZ0LF5W"], "rxcui": ["1797847"], "spl_set_id": ["7bbc6514-bea3-0be0-e673-a8f6069025ff"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (60505-0953-3)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "60505-0953-3", "marketing_start_date": "20200302"}], "brand_name": "Azelastine hydrochloride and Fluticasone propionate", "product_id": "60505-0953_2a316a42-19b9-2939-cda9-71111b40a4c4", "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": "60505-0953", "generic_name": "Azelastine hydrochloride and Fluticasone propionate", "labeler_name": "Apotex Corp.", "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": "ANDA207712", "marketing_category": "ANDA", "marketing_start_date": "20200302", "listing_expiration_date": "20261231"}