Taletrectinib Adipate Capsule
NDC Package 65404-009-99

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Taletrectinib Adipate capsules is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a capsule delivery system. Marketed by Agc Pharma Chemicals Europe, S.l.u., this product is identified by NDC 65404-009.

Identification & Billing

NDC Package Code
65404-009-99
Package Description
1 BAG in 1 DRUM / 1 BAG in 1 BAG (65404-009-02) / 25 CAPSULE in 1 BAG (65404-009-01)
Product Code
65404-009
11-Digit Billing Format
65404000999

Clinical Specifications

Proprietary Name
Taletrectinib Adipate
Non-Proprietary Name
Taletrectinib Adipate
Substance Name
Taletrectinib Adipate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Active Ingredient(s)
TALETRECTINIB ADIPATE 200 mg/1

Regulatory & Marketing

Labeler Name
Agc Pharma Chemicals Europe, S.l.u.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
06-01-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

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.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65404-009-99 identifies a specific commercial package of 1 bag in 1 drum / 1 bag in 1 bag (65404-009-02) / 25 capsule in 1 bag (65404-009-01) of Taletrectinib Adipate (UNFINISHED drug), a bulk ingredient labeled by Agc Pharma Chemicals Europe, S.l.u.. This capsule is formulated for use and contains taletrectinib adipate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Agc Pharma Chemicals Europe, S.l.u. on June 01, 2026. The current certification is valid through December 31, 2027.

How is this Agc Pharma Chemicals Europe, S.l.u. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65404000999. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
65404-009-99
11-Digit CMS (5-4-2)
65404-0009-99

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.