What is NDC 0065-4011?

0065-4011 is the product NDC for Zaditor (ketotifen fumarate), Ketotifen fumarate .25 mg/mL solution, listed with the FDA by Alcon Laboratories, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Alcon Laboratories, Inc., NDC labeler code 0065. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Zaditor?

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.

Zaditor NDC 0065-4011 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0065-4011Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00065-4011Add 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
0065-4011-05	0006540110500065401105	1 BOTTLE, DROPPER in 1 CARTON (0065-4011-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Mar 13, 2013
0065-4011-06	0006540110600065401106	2 BOTTLE, DROPPER in 1 CARTON (0065-4011-06) / 5 mL in 1 BOTTLE, DROPPERMarketed from Jan 8, 2013
0065-4011-11	0006540111100065401111	3 BOTTLE, DROPPER in 1 CARTON (0065-4011-11) / 5 mL in 1 BOTTLE, DROPPERMarketed from Feb 13, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Zaditor
Generic name (nonproprietary): ketotifen fumarate
Active ingredients: Ketotifen fumarate — .25 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Alcon Laboratories, Inc.NDC labeler code 0065
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077200
Marketing start: Jan 8, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0065-4011_bed738a0-2943-46e7-a65e-2440dac7971bSPL ID bed738a0-2943-46e7-a65e-2440dac7971bSPL set ID ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9fRxCUI 284380, 311237UNII HBD503WOROUPC 0300654011057
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

N400065401105 followed by a unit qualifier and the quantity

Package 00065-4011-05. 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 Dec 15, 2023.

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)

About NDC 0065-4011

What is NDC 0065-4011?: 0065-4011 is the product NDC for Zaditor (ketotifen fumarate), Ketotifen fumarate .25 mg/mL solution, listed with the FDA by Alcon Laboratories, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zaditor (Ketotifen fumarate).
What is the active ingredient?: Ketotifen fumarate.
Who is the labeler?: Alcon Laboratories, Inc., NDC labeler code 0065. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zaditor?: 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.

Zaditor (Ketotifen fumarate) NDC 0065-4011