ketotifen fumarate

Generic: ketotifen fumarate

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketotifen fumarate
Generic Name ketotifen fumarate
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ketotifen fumarate .25 mg/mL

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 76385-106
Product ID 76385-106_948d4259-9d62-4bc7-9149-6961034364bf
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204059
Listing Expiration 2026-12-31
Marketing Start 2021-10-15

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 76385106
Hyphenated Format 76385-106

Supplemental Identifiers

RxCUI
311237
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 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 (76385-106-17) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

76385-106-17 1 BOTTLE, PLASTIC in 1 CARTON (76385-106-17) / 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": "948d4259-9d62-4bc7-9149-6961034364bf", "openfda": {"unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["0fe119ad-cb44-4e90-a096-0ed0ba63dc31"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (76385-106-17)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "76385-106-17", "marketing_start_date": "20211015"}], "brand_name": "KETOTIFEN FUMARATE", "product_id": "76385-106_948d4259-9d62-4bc7-9149-6961034364bf", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "76385-106", "generic_name": "KETOTIFEN FUMARATE", "labeler_name": "Unichem Pharmaceuticals (USA), 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": "20211015", "listing_expiration_date": "20261231"}