Package 69168-478-02

Brand: azelastine hydrochloride

Generic: azelastine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 69168-478-02
Digits Only 6916847802
Product NDC 69168-478
Description

2 BOTTLE, SPRAY in 1 CARTON (69168-478-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Marketing

Marketing Status
Marketed Since 2025-09-22
Brand azelastine hydrochloride
Generic azelastine hydrochloride
Sample Package No

Linked Drug Pages (1)

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"}