What is NDC 71205-115?

71205-115 is the product NDC for Ketotifen Fumarate, Ketotifen fumarate .35 mg/mL solution/ drops, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ketotifen Fumarate?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ketotifen Fumarate NDC 71205-115 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-115Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0115Add 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
71205-115-05	7120501150571205011505	1 BOTTLE, DROPPER in 1 CARTON (71205-115-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Sep 4, 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): Ketotifen Fumarate
Generic name (nonproprietary): ketotifen fumarate
Active ingredients: Ketotifen fumarate — .35 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Proficient Rx LPNDC labeler code 71205
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077958
Marketing start: Oct 1, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 71205-115_78139082-90f2-4200-bf95-8a46315597edSPL ID 78139082-90f2-4200-bf95-8a46315597edSPL set ID 3a9e70ab-d188-488c-8c47-a2184eb4ef2cRxCUI 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

N471205011505 followed by a unit qualifier and the quantity

Package 71205-0115-05. 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 Oct 1, 2019.

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 71205-115

What is NDC 71205-115?: 71205-115 is the product NDC for Ketotifen Fumarate, Ketotifen fumarate .35 mg/mL solution/ drops, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ketotifen Fumarate.
What is the active ingredient?: Ketotifen fumarate.
Who is the labeler?: Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ketotifen Fumarate?: 4 other product NDCs are listed under this name. See all Ketotifen Fumarate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ketotifen Fumarate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ketotifen Fumarate	Ketotifen fumarate .25 mg/mL	SolutionOphthalmic	Preferred Pharmaceuticals Inc.	68788-8715	68788-8715-05
Ketotifen Fumarate	Ketotifen fumarate .25 mg/mL	SolutionOphthalmic	Unichem Pharmaceuticals (USA), Inc.	76385-106	76385-0106-17
Ketotifen Fumarate	Ketotifen fumarate .25 mg/mL	Solution/ dropsOphthalmic	Rugby Laboratories	0536-1252	00536-1252-40
Ketotifen Fumarate	Ketotifen fumarate .25 mg/mL	Solution/ dropsOphthalmic	A-S Medication Solutions	50090-6472	50090-6472-00

Other NDCs under ANDA 077958

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

FDA NDC Directory listings under ANDA 077958
Product	Strength	Form · route	Labeler	Product NDC
Eye Itch Reliefketotifen fumarate	Ketotifen fumarate .35 mg/mL	Solution/ dropsOphthalmic	CARDINAL HEALTH 110, LLC. DBA LEADER	70000-0124
Ketotifen Fumarate Ophthalmic Solutionketotifen fumarate	Ketotifen fumarate .25 mg/mL	Solution/ dropsOphthalmic	Preferred Pharmaceuticals Inc.	68788-4084
Ketotifen Fumarate Ophthalmic Solutionketotifen fumarate	Ketotifen fumarate .25 mg/mL	Solution/ dropsOphthalmic	Sentiss Pharmaceuticals LLC	70244-041
Ketotifen Fumarate Ophthalmic Solutionketotifen fumarate	Ketotifen fumarate .25 mg/mL	Solution/ dropsOphthalmic	Armas Pharmaceuticals Inc.	72485-617