Revtorpyk Injection, Powder, For Solution
NDC Package 84577-751-01

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

Package Information

Revtorpyk (gedatolisib) injection is rEVTORPYK is indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting [see Dosage and Administration (2.1) and Clinical Studies (14)]. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Celcuity Inc., this product is identified by NDC 84577-751 and is authorized under FDA application NDA219908.

Identification & Billing

NDC Package Code
84577-751-01
Package Description
1 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
Product Code
84577-751
11-Digit Billing Format
84577075101

Clinical Specifications

Proprietary Name
Revtorpyk
Non-Proprietary Name
Gedatolisib
Substance Name
Gedatolisib
Dosage Form
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
GEDATOLISIB 180 mg/1
Usage Information
REVTORPYK is indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting [see Dosage and Administration (2.1) and Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Celcuity Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA219908
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-14-2026
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 84577-751-01 identifies a specific commercial package of 1 vial, glass in 1 carton / 1 injection, powder, for solution in 1 vial, glass of Revtorpyk, a human prescription drug labeled by Celcuity Inc.. This injection, powder, for solution is formulated for intravenous use and contains gedatolisib 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 Celcuity Inc. on July 14, 2026. The current certification is valid through December 31, 2027.

How is this Celcuity Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84577075101. 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)
84577-751-01
11-Digit CMS (5-4-2)
84577-0751-01

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