Package 68083-287-01

Brand: azelastine hydrochloride

Generic: azelastine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 68083-287-01
Digits Only 6808328701
Product NDC 68083-287
Description

1 BOTTLE, PLASTIC in 1 BOX (68083-287-01) / 6 mL in 1 BOTTLE, PLASTIC

Marketing

Marketing Status
Marketed Since 2020-02-25
Brand azelastine hydrochloride
Generic azelastine hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAOCULAR"], "spl_id": "a29e9f18-dc8f-491a-b502-e26c0d8bfe08", "openfda": {"unii": ["0L591QR10I"], "rxcui": ["860805"], "spl_set_id": ["f358cecd-284f-4d0b-806c-039465220bd2"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (68083-287-01)  / 6 mL in 1 BOTTLE, PLASTIC", "package_ndc": "68083-287-01", "marketing_start_date": "20200225"}], "brand_name": "Azelastine Hydrochloride", "product_id": "68083-287_a29e9f18-dc8f-491a-b502-e26c0d8bfe08", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68083-287", "generic_name": "Azelastine Hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azelastine Hydrochloride", "active_ingredients": [{"name": "AZELASTINE HYDROCHLORIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA210092", "marketing_category": "ANDA", "marketing_start_date": "20200225", "listing_expiration_date": "20261231"}