NDC product

Azelastine Hydrochloride and Fluticasone Propionate

NDC 0378-3458 · Mylan Pharmaceuticals Inc.

Key facts

Product NDC 0378-3458
Proprietary name Azelastine Hydrochloride and Fluticasone Propionate
Nonproprietary name Azelastine Hydrochloride and Fluticasone Propionate
Substances AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE
Dosage form SPRAY, METERED
Route NASAL
Labeler Mylan Pharmaceuticals Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA AUTHORIZED GENERIC
Application number NDA202236
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
Marketing start Apr 14, 2020
Marketing end Feb 28, 2027

At a glance

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory

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