Cligavyx Injection
NDC Package 83831-159-02

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

Package Information

Cligavyx (fulvestrant) injection is fulvestrant is used to treat certain types of breast cancer. This formulation utilizes a injection delivery system. Marketed by Avyxa Pharma, Llc, this product is identified by NDC 83831-159 and is authorized under FDA application NDA210063.

Identification & Billing

NDC Package Code
83831-159-02
Package Description
2 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS
Product Code
83831-159
11-Digit Billing Format
83831015902

Clinical Specifications

Proprietary Name
Cligavyx
Non-Proprietary Name
Fulvestrant
Substance Name
Fulvestrant
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
FULVESTRANT 250 mg/5mL
Pharmacologic Class
Usage Information
Fulvestrant is used to treat certain types of breast cancer. Breast cancer cells need the hormone estrogen in order to grow. Fulvestrant works by blocking the effect of estrogen, slowing tumor cell growth.

Regulatory & Marketing

Labeler Name
Avyxa Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA210063
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-10-2026
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 83831-159-02 identifies a specific commercial package of 2 syringe, glass in 1 carton / 5 ml in 1 syringe, glass of Cligavyx, a human prescription drug labeled by Avyxa Pharma, Llc. This injection is formulated for intramuscular use and contains fulvestrant 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 Avyxa Pharma, Llc on June 10, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Fulvestrant is used to treat certain types of breast cancer. Breast cancer cells need the hormone estrogen in order to grow. Fulvestrant works by blocking the effect of estrogen, slowing tumor cell growth.

How is this Avyxa Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83831015902. 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)
83831-159-02
11-Digit CMS (5-4-2)
83831-0159-02

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