Fulvestrant
NDC Package 68001-424-85

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Fulvestrant is used to treat certain types of breast cancer. Marketed by Bluepoint Laboratories, this product is identified by NDC 68001-424 and is authorized under FDA application ANDA205871.

Identification & Billing

NDC Package Code
68001-424-85
Package Description
2 SYRINGE in 1 CARTON / 5 mL in 1 SYRINGE (68001-424-86)
Product Code
68001-424
11-Digit Billing Format
68001042485
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Fulvestrant
Dosage Form
-
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
Bluepoint Laboratories
FDA Application #
ANDA205871
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2019
End Marketing Date
08-31-2022
Listing Expiration
08-31-2022
Exclude Flag
D
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 68001-424-85 identifies a specific commercial package of 2 syringe in 1 carton / 5 ml in 1 syringe (68001-424-86) of Fulvestrant, labeled by Bluepoint Laboratories. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Bluepoint Laboratories on August 01, 2019. The current certification is valid through August 31, 2022.

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 Bluepoint Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68001042485. 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 (5-3-2)
68001-424-85
11-Digit CMS (5-4-2)
68001-0424-85

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