Over-the-counter drug · NDA

Eye Itch Relief (ketotifen fumarate) NDC 50090-7253

Ketotifen fumarate .25 mg/mL · Solution/ drops · Ophthalmic · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-7253Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-7253Add 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 NDC11-digit (billing)PackageCopy
50090-7253-0500907253001 BOTTLE, DROPPER in 1 CARTON (50090-7253-0) / 5 mL in 1 BOTTLE, DROPPERMarketed from Sep 24, 2024

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)
Eye Itch Relief
Generic name (nonproprietary)
ketotifen fumarate
Active ingredients
Ketotifen fumarate — .25 mg/mL
Dosage form
Solution/ drops
Route
Ophthalmic
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021996
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 50090-7253_f05216a8-6a4a-401d-ad52-d8ce0a408631SPL ID f05216a8-6a4a-401d-ad52-d8ce0a408631SPL set ID b0eb7b54-4f4e-4ca2-8e4e-30d18d662401RxCUI 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

N450090725300 followed by a unit qualifier and the quantity

Package 50090-7253-00. 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 .

Indications (excerpt from the label)

Uses for the temporary relief of itchy eyes due to ragweed, pollen, 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 NDA 021996

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

FDA NDC Directory listings under NDA 021996
ProductStrengthForm · routeLabelerProduct NDC
Eye Itch Reliefketotifen fumarateKetotifen fumarate .25 mg/mLSolution/ dropsOphthalmicPERRIGO DIRECT INC.50804-601
Eye Itch Reliefketotifen fumarateKetotifen fumarate .25 mg/mLSolution/ dropsOphthalmicCVS Pharmacy69842-275
Eye Itch Reliefketotifen fumarateKetotifen fumarate .25 mg/mLSolutionOphthalmicTarget Corporation11673-064
Eye Itch Reliefketotifen fumarateKetotifen fumarate .25 mg/mLSolutionOphthalmicCardinal Health70000-0522
Ketotifen FumarateKetotifen fumarate .25 mg/mLSolution/ dropsOphthalmicRugby Laboratories0536-1252
Eye Itch Reliefketotifen fumarateKetotifen fumarate .25 mg/mLSolutionOphthalmicSafeway21130-601
Alawayketotifen fumarateKetotifen fumarate .25 mg/mLSolution/ dropsOphthalmicBausch & Lomb Incorporated24208-601
Ketotifen FumarateKetotifen fumarate .25 mg/mLSolution/ dropsOphthalmicA-S Medication Solutions50090-6472
Eye Itch Releifketotifen fumarateKetotifen fumarate .25 mg/mLSolution/ dropsOphthalmicRite Aid Corporation11822-5533
Eye Itch Reliefketotifen fumarateKetotifen fumarate .25 mg/mLSolution/ dropsOphthalmicTOPCO ASSOCIATES LLC36800-097
Eye Itch Reliefketotifen fumarateKetotifen fumarate .35 mg/mLSolutionOphthalmicWalgreen Company0363-0038
Equate Eye Itch Reliefketotifen fumarateKetotifen fumarate .25 mg/mLSolutionOphthalmicWal-Mart Stores, Inc.49035-231
Eye Itch Reliefketotifen fumarateKetotifen fumarate .25 mg/mLSolutionOphthalmicRedpharm Drug67296-2245
Eye Itch Reliefketotifen fumarateKetotifen fumarate .25 mg/mLSolution/ dropsOphthalmicKroger Company30142-398

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