Faslodex Injection
NDC Package 0310-0720-10

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

Package Information

Faslodex (fulvestrant) injection is fulvestrant is used to treat certain types of breast cancer. This formulation utilizes a injection delivery system. Marketed by Astrazeneca Pharmaceuticals Lp, this product is identified by NDC 0310-0720 and is authorized under FDA application NDA021344.

Identification & Billing

NDC Package Code
0310-0720-10
Package Description
2 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS
Product Code
0310-0720
11-Digit Billing Format
00310072010
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Faslodex
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 50 mg/mL
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
Astrazeneca Pharmaceuticals Lp
Product Type
Human Prescription Drug
FDA Application #
NDA021344
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-2010
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J9395
Source: ASP
Injection, fulvestrant
HCPCS Dosage 25 MG
Units / Pkg 20

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 0310-0720-10 identifies a specific commercial package of 2 syringe, glass in 1 carton / 5 ml in 1 syringe, glass of Faslodex, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. 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 Astrazeneca Pharmaceuticals Lp on November 01, 2010. 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 Astrazeneca Pharmaceuticals Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00310072010. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0310-0720-10
11-Digit CMS (5-4-2)
00310-0720-10

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