Package 50804-601-05

Brand: eye itch relief

Generic: ketotifen fumarate
NDC Package

Package Facts

Identity

Package NDC 50804-601-05
Digits Only 5080460105
Product NDC 50804-601
Description

1 BOTTLE, DROPPER in 1 CARTON (50804-601-05) / 5 mL in 1 BOTTLE, DROPPER

Marketing

Marketing Status
Marketed Since 2024-04-01
Brand eye itch relief
Generic ketotifen fumarate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["OPHTHALMIC"], "spl_id": "48728697-b0d0-e765-e063-6294a90a6041", "openfda": {"unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["d3049296-0d15-4523-883c-25f8817bc735"], "manufacturer_name": ["PERRIGO DIRECT INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (50804-601-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "50804-601-05", "marketing_start_date": "20240401"}], "brand_name": "Eye Itch Relief", "product_id": "50804-601_48728697-b0d0-e765-e063-6294a90a6041", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "50804-601", "generic_name": "Ketotifen Fumarate", "labeler_name": "PERRIGO DIRECT INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Eye Itch Relief", "active_ingredients": [{"name": "KETOTIFEN FUMARATE", "strength": ".25 mg/mL"}], "application_number": "NDA021996", "marketing_category": "NDA", "marketing_start_date": "20240401", "listing_expiration_date": "20271231"}