Fulvestrant
NDC Package 70534-002-01

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 Hbt Labs, Inc., this product is identified by NDC 70534-002 and is authorized under FDA application ANDA209714.

Identification & Billing

NDC Package Code
70534-002-01
Package Description
2 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS
Product Code
70534-002
11-Digit Billing Format
70534000201

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
Hbt Labs, Inc.
FDA Application #
ANDA209714
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-21-2019
End Marketing Date
11-21-2019
Listing Expiration
11-21-2019
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 70534-002-01 identifies a specific commercial package of 2 syringe, glass in 1 carton / 5 ml in 1 syringe, glass of Fulvestrant, labeled by Hbt Labs, Inc.. 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 Hbt Labs, Inc. on November 21, 2019. The current certification is valid through November 21, 2019.

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 Hbt Labs, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70534000201. 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)
70534-002-01
11-Digit CMS (5-4-2)
70534-0002-01

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