Ketotifen Fumarate Ophthalmic Solution NDC 68788-4084

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-4084Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-4084Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68788-4084-5	68788408405	1 BOTTLE, DROPPER in 1 CARTON (68788-4084-5) / 5 mL in 1 BOTTLE, DROPPERMarketed from Feb 27, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Ketotifen Fumarate Ophthalmic Solution
Generic name (nonproprietary): ketotifen fumarate
Active ingredients: Ketotifen fumarate — .25 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Preferred Pharmaceuticals Inc.
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077958
Marketing start: Feb 27, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 68788-4084_95d70587-2cf2-4e14-8ca3-11b762f1188bSPL ID 95d70587-2cf2-4e14-8ca3-11b762f1188bSPL set ID f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419cRxCUI 311237UNII HBD503WORO
Pharmacologic class: Histamine-1 Receptor Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468788408405 followed by a unit qualifier and the quantity

Package 68788-4084-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Mar 18, 2026.

Indications (excerpt from the label)

Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077958

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077958
Product	Strength	Form · route	Labeler	Product NDC
Ketotifen Fumarate Ophthalmic Solutionketotifen fumarate	Ketotifen fumarate .25 mg/mL	Solution/ dropsOphthalmic	Armas Pharmaceuticals Inc.	72485-617
Ketotifen Fumarate	Ketotifen fumarate .35 mg/mL	Solution/ dropsOphthalmic	Proficient Rx LP	71205-115
Eye Itch Reliefketotifen fumarate	Ketotifen fumarate .35 mg/mL	Solution/ dropsOphthalmic	CARDINAL HEALTH 110, LLC. DBA LEADER	70000-0124
Ketotifen Fumarate Ophthalmic Solutionketotifen fumarate	Ketotifen fumarate .25 mg/mL	Solution/ dropsOphthalmic	Sentiss Pharmaceuticals LLC	70244-041