azelastine hydrochloride and fluticasone propionate

Generic: azelastine hydrochloride and fluticasone propionate

Labeler: teva pharmaceuticals, inc.
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 teva pharmaceuticals, inc.
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

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

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-2157
Product ID 0480-2157_edea3e4b-7afc-4566-864d-acdf480a92af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208436
Listing Expiration 2026-12-31
Marketing Start 2025-09-08

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 04802157
Hyphenated Format 0480-2157

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 ANDA208436 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 137 ug/1
  • 50 ug/1
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (0480-2157-57) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

0480-2157-57 1 BOTTLE, SPRAY in 1 CARTON (0480-2157-57) / 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": "edea3e4b-7afc-4566-864d-acdf480a92af", "openfda": {"unii": ["0L591QR10I", "O2GMZ0LF5W"], "rxcui": ["1797847"], "spl_set_id": ["0d45e7a4-900f-44ef-bb18-a1fbff75a3c6"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (0480-2157-57)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "0480-2157-57", "marketing_start_date": "20250908"}], "brand_name": "Azelastine Hydrochloride and Fluticasone Propionate", "product_id": "0480-2157_edea3e4b-7afc-4566-864d-acdf480a92af", "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": "0480-2157", "generic_name": "Azelastine Hydrochloride and Fluticasone Propionate", "labeler_name": "Teva 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": "ANDA208436", "marketing_category": "ANDA", "marketing_start_date": "20250908", "listing_expiration_date": "20261231"}