Package 82584-307-03

Brand: azasite

Generic: azithromycin monohydrate
NDC Package

Package Facts

Identity

Package NDC 82584-307-03
Digits Only 8258430703
Product NDC 82584-307
Product ID 82584-307_1e292167-581f-b1db-e063-6394a90ae8a1
Description

1 BOTTLE, DROPPER in 1 CARTON (82584-307-03) / 2.5 mL in 1 BOTTLE, DROPPER

Marketing

Marketing Status
Marketed Since 2022-11-01
Brand azasite
Generic azithromycin monohydrate
Sample Package No

Linked Drug Pages (1)

AZASITE ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "1e292167-581f-b1db-e063-6394a90ae8a1", "openfda": {"unii": ["JTE4MNN1MD"], "rxcui": ["706868", "706872"], "spl_set_id": ["0c5d6f5e-18ea-436f-8c62-bbaf66effe3d"], "manufacturer_name": ["Thea Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE, DROPPER in 1 CARTON (82584-307-02)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "82584-307-02", "marketing_start_date": "20221101"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82584-307-03)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "82584-307-03", "marketing_start_date": "20221101"}], "brand_name": "AZASITE", "product_id": "82584-307_1e292167-581f-b1db-e063-6394a90ae8a1", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "82584-307", "generic_name": "azithromycin monohydrate", "labeler_name": "Thea Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZASITE", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "10 mg/mL"}], "application_number": "NDA050810", "marketing_category": "NDA", "marketing_start_date": "20221101", "listing_expiration_date": "20261231"}