dymista

Generic: azelastine hydrochloride and fluticasone propionate

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dymista
Generic Name azelastine hydrochloride and fluticasone propionate
Labeler viatris specialty llc
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

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

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 0037-0245
Product ID 0037-0245_ed1f7ce9-ccfa-4e73-940f-14ea8166d524
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202236
Listing Expiration 2026-12-31
Marketing Start 2016-10-01

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 00370245
Hyphenated Format 0037-0245

Supplemental Identifiers

RxCUI
1797847 1797849
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 dymista (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, SPRAY in 1 BOX (0037-0245-23) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

0037-0245-23 1 BOTTLE, SPRAY in 1 BOX (0037-0245-23) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Ingredients (2)

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

Linked Drug Pages (1)

DYMISTA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "ed1f7ce9-ccfa-4e73-940f-14ea8166d524", "openfda": {"unii": ["0L591QR10I", "O2GMZ0LF5W"], "rxcui": ["1797847", "1797849"], "spl_set_id": ["4c557ec4-c4cf-11df-851a-0800200c9a66"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 BOX (0037-0245-23)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "0037-0245-23", "marketing_start_date": "20161001"}], "brand_name": "DYMISTA", "product_id": "0037-0245_ed1f7ce9-ccfa-4e73-940f-14ea8166d524", "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": "0037-0245", "generic_name": "Azelastine Hydrochloride and Fluticasone Propionate", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DYMISTA", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": "137 ug/1"}, {"name": "FLUTICASONE PROPIONATE", "strength": "50 ug/1"}], "application_number": "NDA202236", "marketing_category": "NDA", "marketing_start_date": "20161001", "listing_expiration_date": "20261231"}