Package 54348-857-01

Brand: azithromycin

Generic: azithromycin monohydrate
NDC Package

Package Facts

Identity

Package NDC 54348-857-01
Digits Only 5434885701
Product NDC 54348-857
Product ID 54348-857_eb018961-75d1-2d69-e053-2995a90a38be
Description

1 BOTTLE in 1 BOX (54348-857-01) / 1 TABLET, FILM COATED in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2019-07-10
Brand azithromycin
Generic azithromycin monohydrate
Sample Package No

Linked Drug Pages (1)

Azithromycin ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eb018961-75d1-2d69-e053-2995a90a38be", "openfda": {"unii": ["JTE4MNN1MD"], "rxcui": ["248656"], "spl_set_id": ["ba57ff26-cd02-4f57-ac92-b613d245a4ea"], "manufacturer_name": ["PharmPak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-857-00)  / 1 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-857-00", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-857-01)  / 1 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-857-01", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-857-02)  / 2 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-857-02", "marketing_start_date": "20190710"}], "brand_name": "Azithromycin", "product_id": "54348-857_eb018961-75d1-2d69-e053-2995a90a38be", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "54348-857", "generic_name": "AZITHROMYCIN MONOHYDRATE", "labeler_name": "PharmPak, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA065225", "marketing_category": "ANDA", "marketing_start_date": "20190710", "listing_expiration_date": "20261231"}