What is NDC 49035-231?

49035-231 is the product NDC for Equate Eye Itch Relief (ketotifen fumarate), Ketotifen fumarate .25 mg/mL solution, listed with the FDA by Wal-Mart Stores, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Equate Eye Itch Relief (Ketotifen fumarate).

Wal-Mart Stores, Inc., NDC labeler code 49035. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Equate Eye Itch Relief?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Equate Eye Itch Relief NDC 49035-231

NDC codes

FDA NDC Directory

Product NDC (as listed)49035-231Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49035-0231Add 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
49035-231-10	4903502311049035023110	1 BOTTLE in 1 CARTON (49035-231-10) / 10 mL in 1 BOTTLEMarketed from Jan 1, 2016
49035-231-11	4903502311149035023111	2 BOTTLE in 1 CARTON (49035-231-11) / 10 mL in 1 BOTTLEMarketed from Jul 2, 2018

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): 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.NDC labeler code 49035
Product type: Over-the-counter drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021996
Marketing start: Jan 1, 2016
Listing expires: Dec 31, 2027
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

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

Current FDA label (SPL), effective Mar 23, 2021.

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)

About NDC 49035-231

What is NDC 49035-231?: 49035-231 is the product NDC for Equate Eye Itch Relief (ketotifen fumarate), Ketotifen fumarate .25 mg/mL solution, listed with the FDA by Wal-Mart Stores, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Equate Eye Itch Relief (Ketotifen fumarate).
What is the active ingredient?: Ketotifen fumarate.
Who is the labeler?: Wal-Mart Stores, Inc., NDC labeler code 49035. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Equate Eye Itch Relief?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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
Product	Strength	Form · route	Labeler	Product NDC
Alawayketotifen fumarate	Ketotifen fumarate .25 mg/mL	Solution/ dropsOphthalmic	Bausch & Lomb Incorporated	24208-601
Eye Itch Reliefketotifen fumarate	Ketotifen fumarate .35 mg/mL	SolutionOphthalmic	Walgreen Company	0363-0038
Eye Itch Reliefketotifen fumarate	Ketotifen fumarate .25 mg/mL	SolutionOphthalmic	Target Corporation	11673-064
Eye Itch Reliefketotifen fumarate	Ketotifen fumarate .25 mg/mL	SolutionOphthalmic	Safeway	21130-601
Eye Itch Reliefketotifen fumarate	Ketotifen fumarate .25 mg/mL	Solution/ dropsOphthalmic	Kroger Company	30142-398
Eye Itch Reliefketotifen fumarate	Ketotifen fumarate .25 mg/mL	Solution/ dropsOphthalmic	TOPCO ASSOCIATES LLC	36800-097
Eye Itch Reliefketotifen fumarate	Ketotifen fumarate .25 mg/mL	Solution/ dropsOphthalmic	A-S Medication Solutions	50090-7253
Eye Itch Reliefketotifen fumarate	Ketotifen fumarate .25 mg/mL	Solution/ dropsOphthalmic	PERRIGO DIRECT INC.	50804-601
Eye Itch Reliefketotifen fumarate	Ketotifen fumarate .25 mg/mL	SolutionOphthalmic	Redpharm Drug	67296-2245
Eye Itch Reliefketotifen fumarate	Ketotifen fumarate .25 mg/mL	Solution/ dropsOphthalmic	CVS Pharmacy	69842-275
Eye Itch Reliefketotifen fumarate	Ketotifen fumarate .25 mg/mL	SolutionOphthalmic	Cardinal Health	70000-0522
Ketotifen Fumarate	Ketotifen fumarate .25 mg/mL	Solution/ dropsOphthalmic	Rugby Laboratories	0536-1252
Ketotifen Fumarate	Ketotifen fumarate .25 mg/mL	Solution/ dropsOphthalmic	A-S Medication Solutions	50090-6472

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