azelastine hydrochloride

Generic: azelastine hydrochloride

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azelastine hydrochloride
Generic Name azelastine hydrochloride
Labeler allegiant health
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

azelastine hydrochloride 205.5 ug/1

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-478
Product ID 69168-478_fc930f5c-a2b9-4e66-814d-ca8d68cc2d29
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216421
Listing Expiration 2026-12-31
Marketing Start 2025-05-02

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 69168478
Hyphenated Format 69168-478

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 ANDA216421 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 205.5 ug/1
source: ndc
Packaging
  • 2 BOTTLE, SPRAY in 1 CARTON (69168-478-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
  • 1 BOTTLE, SPRAY in 1 CARTON (69168-478-63) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (2)

69168-478-02 2 BOTTLE, SPRAY in 1 CARTON (69168-478-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY 69168-478-63 1 BOTTLE, SPRAY in 1 CARTON (69168-478-63) / 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": "fc930f5c-a2b9-4e66-814d-ca8d68cc2d29", "openfda": {"unii": ["0L591QR10I"], "rxcui": ["1797883"], "spl_set_id": ["3e2fdb0d-c2f5-41ab-b1cd-4fae80648112"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE, SPRAY in 1 CARTON (69168-478-02)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "69168-478-02", "marketing_start_date": "20250922"}, {"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (69168-478-63)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "69168-478-63", "marketing_start_date": "20250922"}], "brand_name": "AZELASTINE HYDROCHLORIDE", "product_id": "69168-478_fc930f5c-a2b9-4e66-814d-ca8d68cc2d29", "dosage_form": "SPRAY, METERED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69168-478", "generic_name": "AZELASTINE HYDROCHLORIDE", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "AZELASTINE HYDROCHLORIDE", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": "205.5 ug/1"}], "application_number": "ANDA216421", "marketing_category": "ANDA", "marketing_start_date": "20250502", "listing_expiration_date": "20261231"}