NDC Package 0065-8595-02 Tryptyr

Acoltremon Solution Ophthalmic; Topical - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0065-8595-02
Package Description:
12 POUCH in 1 CARTON / 5 VIAL in 1 POUCH / .4 mL in 1 VIAL
Product Code:
Proprietary Name:
Tryptyr
Non-Proprietary Name:
Acoltremon
Substance Name:
Acoltremon
Usage Information:
TRYPTYR is indicated for the treatment of the signs and symptoms of dry eye disease.
11-Digit NDC Billing Format:
00065859502
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Alcon Laboratories, Inc.
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s):
  • Ophthalmic - Administration to the external eye.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s):
Sample Package:
No
FDA Application Number:
NDA217370
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
06-13-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0065-8595-013 POUCH in 1 CARTON / 5 VIAL in 1 POUCH / .4 mL in 1 VIAL

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Frequently Asked Questions

What is NDC 0065-8595-02?

The NDC Packaged Code 0065-8595-02 is assigned to a package of 12 pouch in 1 carton / 5 vial in 1 pouch / .4 ml in 1 vial of Tryptyr, a human prescription drug labeled by Alcon Laboratories, Inc.. The product's dosage form is solution and is administered via ophthalmic; topical form.

Is NDC 0065-8595 included in the NDC Directory?

Yes, Tryptyr with product code 0065-8595 is active and included in the NDC Directory. The product was first marketed by Alcon Laboratories, Inc. on June 13, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0065-8595-02?

The 11-digit format is 00065859502. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20065-8595-025-4-200065-8595-02