Equate Eye Itch Relief (ketotifen fumarate) NDC 49035-231

Product information

Brand name (proprietary)

Equate Eye Itch Relief

Generic name (nonproprietary)

ketotifen fumarate

Active ingredients

Ketotifen fumarate — .25 mg/mL

Dosage form

Solution

Route

Ophthalmic

Labeler

Wal-Mart Stores, Inc.

Product type

Over-the-counter drug

Marketing category

NDA — New Drug ApplicationApplication NDA 021996

Marketing start

Jan 1, 2016

Listing expires

Dec 31, 2026

Other FDA classes

Histamine H1 Receptor Antagonists (Mechanism)

Identifiers

Product ID 49035-231_23a94887-f625-4a01-bcda-131ca5286372SPL ID 23a94887-f625-4a01-bcda-131ca5286372SPL set ID accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9RxCUI 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

N449035023110 followed by a unit qualifier and the quantity Copy

Package 49035-0231-10. 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

Other NDCs under NDA 021996

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