zaditor

Generic: ketotifen fumarate

Labeler: alcon laboratories, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zaditor
Generic Name ketotifen fumarate
Labeler alcon laboratories, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ketotifen fumarate .25 mg/mL

Manufacturer
Alcon Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0065-4011
Product ID 0065-4011_bed738a0-2943-46e7-a65e-2440dac7971b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077200
Listing Expiration 2026-12-31
Marketing Start 2013-01-08

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 00654011
Hyphenated Format 0065-4011

Supplemental Identifiers

RxCUI
284380 311237
UPC
0300654011057
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 zaditor (source: ndc)
Generic Name ketotifen fumarate (source: ndc)
Application Number ANDA077200 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .25 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0065-4011-05) / 5 mL in 1 BOTTLE, DROPPER
  • 2 BOTTLE, DROPPER in 1 CARTON (0065-4011-06) / 5 mL in 1 BOTTLE, DROPPER
  • 3 BOTTLE, DROPPER in 1 CARTON (0065-4011-11) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

0065-4011-05 1 BOTTLE, DROPPER in 1 CARTON (0065-4011-05) / 5 mL in 1 BOTTLE, DROPPER 0065-4011-06 2 BOTTLE, DROPPER in 1 CARTON (0065-4011-06) / 5 mL in 1 BOTTLE, DROPPER 0065-4011-11 3 BOTTLE, DROPPER in 1 CARTON (0065-4011-11) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

ketotifen fumarate (.25 mg/mL)

Linked Drug Pages (1)

Zaditor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "bed738a0-2943-46e7-a65e-2440dac7971b", "openfda": {"upc": ["0300654011057"], "unii": ["HBD503WORO"], "rxcui": ["284380", "311237"], "spl_set_id": ["ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0065-4011-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-4011-05", "marketing_start_date": "20130313"}, {"sample": false, "description": "2 BOTTLE, DROPPER in 1 CARTON (0065-4011-06)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-4011-06", "marketing_start_date": "20130108"}, {"sample": false, "description": "3 BOTTLE, DROPPER in 1 CARTON (0065-4011-11)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-4011-11", "marketing_start_date": "20150213"}], "brand_name": "Zaditor", "product_id": "0065-4011_bed738a0-2943-46e7-a65e-2440dac7971b", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "0065-4011", "generic_name": "ketotifen fumarate", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Zaditor", "active_ingredients": [{"name": "KETOTIFEN FUMARATE", "strength": ".25 mg/mL"}], "application_number": "ANDA077200", "marketing_category": "ANDA", "marketing_start_date": "20130108", "listing_expiration_date": "20261231"}