Zegfrovy Tablet, Film Coated
NDC Package 84694-101-01

11-digit billing NDC: 84694010101
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Zegfrovy (sunvozertinib) tablets is zEGFROVY is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1)], whose disease has progressed on or after platinum-based chemotherapy. This formulation utilizes a tablet, film coated delivery system. Marketed by Dizal Pharmaceutical Co., Ltd., this product is identified by NDC 84694-101 and is authorized under FDA application NDA219839.

Identification & Billing

NDC Package Code
84694-101-01
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code
84694-101
11-Digit Billing Format
84694010101

Clinical Specifications

Proprietary Name
Zegfrovy
Non-Proprietary Name
Sunvozertinib
Substance Name
Sunvozertinib
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)
SUNVOZERTINIB 150 mg/1
Usage Information
ZEGFROVY is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1)], whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Regulatory & Marketing

Labeler Name
Dizal Pharmaceutical Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
NDA219839
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-22-2026
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 84694-101-01 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Zegfrovy, a human prescription drug labeled by Dizal Pharmaceutical Co., Ltd.. This tablet, film coated is formulated for oral use and contains sunvozertinib 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 Dizal Pharmaceutical Co., Ltd. on October 22, 2026. The current certification is valid through December 31, 2027.

How is this Dizal Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84694010101. 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)
84694-101-01
11-Digit CMS (5-4-2)
84694-0101-01

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