ketotifen fumarate

Generic: ketotifen fumarate

Labeler: proficient rx lp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketotifen fumarate
Generic Name ketotifen fumarate
Labeler proficient rx lp
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketotifen fumarate .35 mg/mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-115
Product ID 71205-115_78139082-90f2-4200-bf95-8a46315597ed
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077958
Listing Expiration 2026-12-31
Marketing Start 2007-10-01

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 71205115
Hyphenated Format 71205-115

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 ANDA077958 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .35 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (71205-115-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

71205-115-05 1 BOTTLE, DROPPER in 1 CARTON (71205-115-05) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

ketotifen fumarate (.35 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": "78139082-90f2-4200-bf95-8a46315597ed", "openfda": {"unii": ["HBD503WORO"], "rxcui": ["311237"], "spl_set_id": ["3a9e70ab-d188-488c-8c47-a2184eb4ef2c"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (71205-115-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "71205-115-05", "marketing_start_date": "20180904"}], "brand_name": "Ketotifen Fumarate", "product_id": "71205-115_78139082-90f2-4200-bf95-8a46315597ed", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "71205-115", "generic_name": "Ketotifen Fumarate", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ketotifen Fumarate", "active_ingredients": [{"name": "KETOTIFEN FUMARATE", "strength": ".35 mg/mL"}], "application_number": "ANDA077958", "marketing_category": "ANDA", "marketing_start_date": "20071001", "listing_expiration_date": "20261231"}