ketotifen fumarate ophthalmic solution

Generic: ketotifen fumarate

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

Drug Facts

Product Profile

Brand Name ketotifen fumarate ophthalmic solution
Generic Name ketotifen fumarate
Labeler armas pharmaceuticals inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketotifen fumarate .25 mg/mL

Manufacturer
Armas Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72485-617
Product ID 72485-617_cd02d900-5bfc-494b-a588-8f6098fe058e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077958
Listing Expiration 2026-12-31
Marketing Start 2023-10-09

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 72485617
Hyphenated Format 72485-617

Supplemental Identifiers

RxCUI
311237
UPC
0372485617104
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 ophthalmic solution (source: ndc)
Generic Name ketotifen fumarate (source: ndc)
Application Number ANDA077958 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .25 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (72485-617-10) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

72485-617-10 1 BOTTLE, DROPPER in 1 CARTON (72485-617-10) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

ketotifen fumarate (.25 mg/mL)

Linked Drug Pages (1)

Ketotifen Fumarate Ophthalmic Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "cd02d900-5bfc-494b-a588-8f6098fe058e", "openfda": {"upc": ["0372485617104"], "unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3"], "manufacturer_name": ["Armas Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (72485-617-10)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "72485-617-10", "marketing_start_date": "20231009"}], "brand_name": "Ketotifen Fumarate Ophthalmic Solution", "product_id": "72485-617_cd02d900-5bfc-494b-a588-8f6098fe058e", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "72485-617", "generic_name": "Ketotifen Fumarate", "labeler_name": "Armas Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ketotifen Fumarate Ophthalmic Solution", "active_ingredients": [{"name": "KETOTIFEN FUMARATE", "strength": ".25 mg/mL"}], "application_number": "ANDA077958", "marketing_category": "ANDA", "marketing_start_date": "20231009", "listing_expiration_date": "20261231"}