eye itch relief

Generic: ketotifen fumarate

Labeler: cardinal health 110, llc. dba leader
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eye itch relief
Generic Name ketotifen fumarate
Labeler cardinal health 110, llc. dba leader
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketotifen fumarate .35 mg/mL

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER

Identifiers & Regulatory

Product NDC 70000-0124
Product ID 70000-0124_0c2e7ac9-3977-48ba-995c-004dba0d0ad5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077958
Marketing Start 2017-01-18
Marketing End 2028-03-31

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000124
Hyphenated Format 70000-0124

Supplemental Identifiers

RxCUI
311237
UPC
0096295128901
UNII
HBD503WORO

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name eye itch relief (source: ndc)
Generic Name ketotifen fumarate (source: ndc)
Application Number ANDA077958 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .35 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (70000-0124-1) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

70000-0124-1 1 BOTTLE, DROPPER in 1 CARTON (70000-0124-1) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

ketotifen fumarate (.35 mg/mL)

Linked Drug Pages (1)

Eye Itch Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "0c2e7ac9-3977-48ba-995c-004dba0d0ad5", "openfda": {"upc": ["0096295128901"], "unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["add414c5-b6c5-4bb5-8d8a-ddc507a27131"], "manufacturer_name": ["CARDINAL HEALTH 110, LLC. DBA LEADER"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (70000-0124-1)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "70000-0124-1", "marketing_end_date": "20280331", "marketing_start_date": "20170118"}], "brand_name": "Eye Itch Relief", "product_id": "70000-0124_0c2e7ac9-3977-48ba-995c-004dba0d0ad5", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "70000-0124", "generic_name": "Ketotifen Fumarate", "labeler_name": "CARDINAL HEALTH 110, LLC. DBA LEADER", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Eye Itch Relief", "active_ingredients": [{"name": "KETOTIFEN FUMARATE", "strength": ".35 mg/mL"}], "application_number": "ANDA077958", "marketing_category": "ANDA", "marketing_end_date": "20280331", "marketing_start_date": "20170118"}