azelastine hcl

Generic: azelastine

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hcl
Generic Name azelastine
Labeler amneal pharmaceuticals ny llc
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

azelastine hydrochloride 205.5 ug/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2147
Product ID 69238-2147_125e35a1-2e6f-4646-aad2-d6465917671c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216576
Listing Expiration 2026-12-31
Marketing Start 2024-06-07

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692382147
Hyphenated Format 69238-2147

Supplemental Identifiers

RxCUI
1797883
UPC
0365162706840
UNII
0L591QR10I

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 hcl (source: ndc)
Generic Name azelastine (source: ndc)
Application Number ANDA216576 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 205.5 ug/1
source: ndc
Packaging
  • 200 CARTON in 1 BOTTLE (69238-2147-3) / 1 SPRAY, METERED in 1 CARTON
source: ndc

Packages (1)

69238-2147-3 200 CARTON in 1 BOTTLE (69238-2147-3) / 1 SPRAY, METERED in 1 CARTON

Ingredients (1)

azelastine hydrochloride (205.5 ug/1)

Linked Drug Pages (1)

Azelastine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "125e35a1-2e6f-4646-aad2-d6465917671c", "openfda": {"upc": ["0365162706840"], "unii": ["0L591QR10I"], "rxcui": ["1797883"], "spl_set_id": ["82610437-25f4-4ae0-9d6a-381e9932f87d"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 CARTON in 1 BOTTLE (69238-2147-3)  / 1 SPRAY, METERED in 1 CARTON", "package_ndc": "69238-2147-3", "marketing_start_date": "20240607"}], "brand_name": "Azelastine HCl", "product_id": "69238-2147_125e35a1-2e6f-4646-aad2-d6465917671c", "dosage_form": "SPRAY, METERED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69238-2147", "generic_name": "Azelastine", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Azelastine HCl", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": "205.5 ug/1"}], "application_number": "ANDA216576", "marketing_category": "ANDA", "marketing_start_date": "20240607", "listing_expiration_date": "20261231"}