ketotifen fumarate

Generic: ketotifen fumarate

Labeler: a-s medication solutions
NDC Directory HUMAN OTC DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name ketotifen fumarate
Generic Name ketotifen fumarate
Labeler a-s medication solutions
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketotifen fumarate .25 mg/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6472
Product ID 50090-6472_9b869ed6-cd2a-48b5-84b1-c5e0e1f29a89
Product Type HUMAN OTC DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021996
Listing Expiration 2026-12-31
Marketing Start 2020-09-18

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 500906472
Hyphenated Format 50090-6472

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 NDA021996 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .25 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (50090-6472-0) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

50090-6472-0 1 BOTTLE, DROPPER in 1 CARTON (50090-6472-0) / 5 mL in 1 BOTTLE, DROPPER

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": "9b869ed6-cd2a-48b5-84b1-c5e0e1f29a89", "openfda": {"unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["1234de19-257c-422c-8706-1239381a2706"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (50090-6472-0)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "50090-6472-0", "marketing_start_date": "20230510"}], "brand_name": "Ketotifen Fumarate", "product_id": "50090-6472_9b869ed6-cd2a-48b5-84b1-c5e0e1f29a89", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "50090-6472", "generic_name": "Ketotifen Fumarate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ketotifen Fumarate", "active_ingredients": [{"name": "KETOTIFEN FUMARATE", "strength": ".25 mg/mL"}], "application_number": "NDA021996", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20200918", "listing_expiration_date": "20261231"}