What is NDC 0065-8595?

0065-8595 is the product NDC for Tryptyr (acoltremon), Acoltremon .03 mg/mL solution, listed with the FDA by Alcon Laboratories, Inc.. It has 2 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 Tryptyr?

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.

Tryptyr NDC 0065-8595 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0065-8595Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00065-8595Add 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
0065-8595-01	00065859501	3 POUCH in 1 CARTON (0065-8595-01) / 5 VIAL in 1 POUCH / .4 mL in 1 VIALMarketed from Jul 23, 2025 · Sample package
0065-8595-02	00065859502	12 POUCH in 1 CARTON (0065-8595-02) / 5 VIAL in 1 POUCH / .4 mL in 1 VIALMarketed from Jul 23, 2025

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): Tryptyr
Generic name (nonproprietary): acoltremon
Active ingredients: Acoltremon — .03 mg/mL
Dosage form: Solution
Route: Ophthalmic, Topical
Labeler: Alcon Laboratories, Inc.NDC labeler code 0065
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 217370
Marketing start: Jul 23, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 0065-8595_27fdd84a-2d62-4c79-afb0-5d5bd608fdfcSPL ID 27fdd84a-2d62-4c79-afb0-5d5bd608fdfcSPL set ID 2b7715a1-035c-4002-b582-5238efee5d58RxCUI 2716821, 2716826UNII 1L7BVT4Z4Z

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, Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400065859501 followed by a unit qualifier and the quantity

Package 00065-8595-01. 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 18, 2025.

Indications (excerpt from the label)

TRYPTYR is indicated for the treatment of the signs and symptoms of dry eye disease. TRYPTYR is a TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0065-8595

What is NDC 0065-8595?: 0065-8595 is the product NDC for Tryptyr (acoltremon), Acoltremon .03 mg/mL solution, listed with the FDA by Alcon Laboratories, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tryptyr (Acoltremon).
What is the active ingredient?: Acoltremon.
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 Tryptyr?: 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.

Tryptyr (Acoltremon) NDC 0065-8595