NDC product

Ketotifen Fumarate

NDC 0536-1252 · Rugby Laboratories

Key facts

Product NDC 0536-1252
Proprietary name Ketotifen Fumarate
Nonproprietary name Ketotifen Fumarate
Substances KETOTIFEN FUMARATE
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Rugby Laboratories
Product type HUMAN OTC DRUG
Marketing category NDA AUTHORIZED GENERIC
Application number NDA021996
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
Marketing start Sep 18, 2020
Listing certified through Dec 31, 2027

At a glance

  • 1–9 Package NDCs

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

Browse all National Drug Codes (NDC)