Ketotifen Fumarate NDC 76385-106

NDC codes

FDA NDC Directory

Product NDC (as listed)76385-106Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76385-0106Add 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
76385-106-17	76385010617	1 BOTTLE, PLASTIC in 1 CARTON (76385-106-17) / 5 mL in 1 BOTTLE, PLASTICMarketed from Oct 15, 2021

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
Generic name (nonproprietary): ketotifen fumarate
Active ingredients: Ketotifen fumarate — .25 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Unichem Pharmaceuticals (USA), Inc.
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204059
Marketing start: Oct 15, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 76385-106_948d4259-9d62-4bc7-9149-6961034364bfSPL ID 948d4259-9d62-4bc7-9149-6961034364bfSPL set ID 0fe119ad-cb44-4e90-a096-0ed0ba63dc31RxCUI 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

N476385010617 followed by a unit qualifier and the quantity

Package 76385-0106-17. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 204059

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

FDA NDC Directory listings under ANDA 204059
Product	Strength	Form · route	Labeler	Product NDC
Ketotifen Fumarate	Ketotifen fumarate .25 mg/mL	SolutionOphthalmic	Preferred Pharmaceuticals Inc.	68788-8715