ketotifen fumarate

Generic: ketotifen fumarate

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketotifen fumarate
Generic Name ketotifen fumarate
Labeler preferred pharmaceuticals inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ketotifen fumarate .25 mg/mL

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8715
Product ID 68788-8715_3a60d5b4-18cb-418c-97bc-36b27769e391
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204059
Listing Expiration 2026-12-31
Marketing Start 2024-07-12

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 687888715
Hyphenated Format 68788-8715

Supplemental Identifiers

RxCUI
311237
UNII
HBD503WORO

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 ketotifen fumarate (source: ndc)
Generic Name ketotifen fumarate (source: ndc)
Application Number ANDA204059 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .25 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (68788-8715-5) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

68788-8715-5 1 BOTTLE, PLASTIC in 1 CARTON (68788-8715-5) / 5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

ketotifen fumarate (.25 mg/mL)

Linked Drug Pages (1)

Ketotifen Fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "3a60d5b4-18cb-418c-97bc-36b27769e391", "openfda": {"unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["5196ec5b-42d9-40db-a77a-c00360b8cee6"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (68788-8715-5)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "68788-8715-5", "marketing_start_date": "20240712"}], "brand_name": "Ketotifen Fumarate", "product_id": "68788-8715_3a60d5b4-18cb-418c-97bc-36b27769e391", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "68788-8715", "generic_name": "Ketotifen Fumarate", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ketotifen Fumarate", "active_ingredients": [{"name": "KETOTIFEN FUMARATE", "strength": ".25 mg/mL"}], "application_number": "ANDA204059", "marketing_category": "ANDA", "marketing_start_date": "20240712", "listing_expiration_date": "20261231"}