azelastine hydrochloride and fluticasone propionate

Generic: azelastine hydrochloride, fluticasone propionate

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hydrochloride and fluticasone propionate
Generic Name azelastine hydrochloride, fluticasone propionate
Labeler padagis israel pharmaceuticals ltd
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

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

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-066
Product ID 45802-066_26745ea7-7084-4000-9571-5795c176cc6f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208111
Listing Expiration 2026-12-31
Marketing Start 2021-03-01

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 45802066
Hyphenated Format 45802-066

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, fluticasone propionate (source: ndc)
Application Number ANDA208111 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 137 ug/1
  • 50 ug/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (45802-066-01) / 120 SPRAY, METERED in 1 BOTTLE
source: ndc

Packages (1)

45802-066-01 1 BOTTLE in 1 CARTON (45802-066-01) / 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": "26745ea7-7084-4000-9571-5795c176cc6f", "openfda": {"unii": ["0L591QR10I", "O2GMZ0LF5W"], "rxcui": ["1797847"], "spl_set_id": ["625ffdd0-8486-49af-8e77-6aa663be5ac7"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (45802-066-01)  / 120 SPRAY, METERED in 1 BOTTLE", "package_ndc": "45802-066-01", "marketing_start_date": "20210301"}], "brand_name": "AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE", "product_id": "45802-066_26745ea7-7084-4000-9571-5795c176cc6f", "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": "45802-066", "generic_name": "azelastine hydrochloride, fluticasone propionate", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "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": "ANDA208111", "marketing_category": "ANDA", "marketing_start_date": "20210301", "listing_expiration_date": "20261231"}