ketotifen fumarate

Generic: ketotifen fumarate

Labeler: rugby laboratories
NDC Directory HUMAN OTC DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name ketotifen fumarate
Generic Name ketotifen fumarate
Labeler rugby laboratories
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketotifen fumarate .25 mg/mL

Manufacturer
Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-1252
Product ID 0536-1252_d4082ec4-f5c5-4f0d-be97-89f44f6aa52c
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 05361252
Hyphenated Format 0536-1252

Supplemental Identifiers

RxCUI
311237
UPC
0305361252403
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 NDA021996 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .25 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0536-1252-40) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

0536-1252-40 1 BOTTLE, DROPPER in 1 CARTON (0536-1252-40) / 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": "d4082ec4-f5c5-4f0d-be97-89f44f6aa52c", "openfda": {"upc": ["0305361252403"], "unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["8aa81ae9-112a-49fa-a0cb-ed0217a40de5"], "manufacturer_name": ["Rugby Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0536-1252-40)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0536-1252-40", "marketing_start_date": "20200918"}], "brand_name": "Ketotifen Fumarate", "product_id": "0536-1252_d4082ec4-f5c5-4f0d-be97-89f44f6aa52c", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "0536-1252", "generic_name": "Ketotifen Fumarate", "labeler_name": "Rugby Laboratories", "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"}