azelastine hydrochloride

Generic: azelastine hydrochloride

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hydrochloride
Generic Name azelastine hydrochloride
Labeler aurohealth llc
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

azelastine hydrochloride 205.5 ug/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-020
Product ID 58602-020_408b5706-3b4c-4eaf-8d03-b4e26485c06b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216561
Listing Expiration 2026-12-31
Marketing Start 2025-01-27

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 58602020
Hyphenated Format 58602-020

Supplemental Identifiers

RxCUI
1797883
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 hydrochloride (source: ndc)
Generic Name azelastine hydrochloride (source: ndc)
Application Number ANDA216561 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 205.5 ug/1
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (58602-020-07) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY
  • 1 BOTTLE, SPRAY in 1 CARTON (58602-020-51) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY
  • 1 BOTTLE, SPRAY in 1 CARTON (58602-020-52) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (3)

58602-020-07 1 BOTTLE, SPRAY in 1 CARTON (58602-020-07) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY 58602-020-51 1 BOTTLE, SPRAY in 1 CARTON (58602-020-51) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY 58602-020-52 1 BOTTLE, SPRAY in 1 CARTON (58602-020-52) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Ingredients (1)

azelastine hydrochloride (205.5 ug/1)

Linked Drug Pages (1)

AZELASTINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "408b5706-3b4c-4eaf-8d03-b4e26485c06b", "openfda": {"unii": ["0L591QR10I"], "rxcui": ["1797883"], "spl_set_id": ["7281c597-651e-4425-8208-7637cd9d3500"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (58602-020-07)  / 200 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "58602-020-07", "marketing_start_date": "20250127"}, {"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (58602-020-51)  / 60 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "58602-020-51", "marketing_start_date": "20250127"}, {"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (58602-020-52)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "58602-020-52", "marketing_start_date": "20250127"}], "brand_name": "AZELASTINE HYDROCHLORIDE", "product_id": "58602-020_408b5706-3b4c-4eaf-8d03-b4e26485c06b", "dosage_form": "SPRAY, METERED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "58602-020", "generic_name": "AZELASTINE HYDROCHLORIDE", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "AZELASTINE HYDROCHLORIDE", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": "205.5 ug/1"}], "application_number": "ANDA216561", "marketing_category": "ANDA", "marketing_start_date": "20250127", "listing_expiration_date": "20261231"}