Package 53746-831-53
Brand: ciprofloxacin and dexamethasone
Generic: ciprofloxacin and dexamethasonePackage Facts
Identity
Package NDC
53746-831-53
Digits Only
5374683153
Product NDC
53746-831
Description
1 BOTTLE, PLASTIC in 1 CARTON (53746-831-53) / 7.5 mL in 1 BOTTLE, PLASTIC
Marketing
Marketing Status
Brand
ciprofloxacin and dexamethasone
Generic
ciprofloxacin and dexamethasone
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["AURICULAR (OTIC)"], "spl_id": "718cd533-d887-4ef1-a7d0-fca696242bb2", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["4BA73M5E37", "7S5I7G3JQL"], "rxcui": ["403908"], "spl_set_id": ["55426495-5fd1-44ca-afcc-ffbbb0a0a569"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (53746-831-53) / 7.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "53746-831-53", "marketing_start_date": "20240326"}], "brand_name": "Ciprofloxacin and Dexamethasone", "product_id": "53746-831_718cd533-d887-4ef1-a7d0-fca696242bb2", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "53746-831", "generic_name": "Ciprofloxacin and Dexamethasone", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin and Dexamethasone", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "3 mg/mL"}, {"name": "DEXAMETHASONE", "strength": "1 mg/mL"}], "application_number": "ANDA216501", "marketing_category": "ANDA", "marketing_start_date": "20240326", "listing_expiration_date": "20261231"}