Package 36800-097-05

Brand: eye itch relief

Generic: ketotifen fumarate
NDC Package

Package Facts

Identity

Package NDC 36800-097-05
Digits Only 3680009705
Product NDC 36800-097
Description

1 BOTTLE, DROPPER in 1 CARTON (36800-097-05) / 5 mL in 1 BOTTLE, DROPPER

Marketing

Marketing Status
Marketed Since 2022-03-15
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": "6ca0ed6a-4b37-44b1-97d1-7855ab238077", "openfda": {"upc": ["0036800489714"], "unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["b723daa3-6c6f-4a96-a15d-0d5866f28ca4"], "manufacturer_name": ["TOPCO ASSOCIATES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (36800-097-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "36800-097-05", "marketing_start_date": "20220315"}], "brand_name": "Eye Itch Relief", "product_id": "36800-097_6ca0ed6a-4b37-44b1-97d1-7855ab238077", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "36800-097", "generic_name": "ketotifen fumarate", "labeler_name": "TOPCO ASSOCIATES LLC", "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": "20220315", "listing_expiration_date": "20261231"}