Package 64980-448-01

Brand: neomycin and polymyxin b sulfates and hydrocortisone otic suspension

Generic: neomycin and polymyxin b sulfates and hydrocortisone otic
NDC Package

Package Facts

Identity

Package NDC 64980-448-01
Digits Only 6498044801
Product NDC 64980-448
Description

1 BOTTLE in 1 CARTON (64980-448-01) / 10 mL in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2019-03-15
Brand neomycin and polymyxin b sulfates and hydrocortisone otic suspension
Generic neomycin and polymyxin b sulfates and hydrocortisone otic
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["AURICULAR (OTIC)"], "spl_id": "4b15047c-4c19-4562-ba03-5c1aff192a2f", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ", "057Y626693", "19371312D4"], "rxcui": ["310687"], "spl_set_id": ["35768adc-b578-4c2e-b461-22de3135a789"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (64980-448-01)  / 10 mL in 1 BOTTLE", "package_ndc": "64980-448-01", "marketing_start_date": "20190315"}], "brand_name": "Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension", "product_id": "64980-448_4b15047c-4c19-4562-ba03-5c1aff192a2f", "dosage_form": "SUSPENSION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "64980-448", "generic_name": "neomycin and polymyxin B sulfates and hydrocortisone otic", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/mL"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/mL"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/mL"}], "application_number": "NDA060613", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190315", "listing_expiration_date": "20261231"}