Jideytro Tablet, Film Coated
NDC Package 85001-101-01

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

Package Information

Jideytro (zidesamtinib) tablets is jIDEYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor [see Dosage and Administration (2.1), Clinical Studies (14.1)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Nuvalent, Inc., this product is identified by NDC 85001-101 and is authorized under FDA application NDA220185.

Identification & Billing

NDC Package Code
85001-101-01
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code
85001-101
11-Digit Billing Format
85001010101

Clinical Specifications

Proprietary Name
Jideytro
Non-Proprietary Name
Zidesamtinib
Substance Name
Zidesamtinib
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ZIDESAMTINIB 25 mg/1
Usage Information
JIDEYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor [see Dosage and Administration (2.1), Clinical Studies (14.1)].

Regulatory & Marketing

Labeler Name
Nuvalent, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA220185
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-22-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

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 85001-101-01 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Jideytro, a human prescription drug labeled by Nuvalent, Inc.. This tablet, film coated is formulated for oral use and contains zidesamtinib 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 Nuvalent, Inc. on July 22, 2026. The current certification is valid through December 31, 2027.

How is this Nuvalent, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85001010101. 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)
85001-101-01
11-Digit CMS (5-4-2)
85001-0101-01

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