Tamoxifen Citrate Powder
NDC Package 65319-1051-2

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Tamoxifen Citrate powders is tamoxifen is used to treat breast cancer. This formulation utilizes a powder delivery system. Marketed by Chemische Fabrik Berg Gmbh, this product is identified by NDC 65319-1051.

Identification & Billing

NDC Package Code
65319-1051-2
Package Description
10 kg in 1 DRUM
Product Code
65319-1051
11-Digit Billing Format
65319105102

Clinical Specifications

Proprietary Name
Tamoxifen Citrate
Non-Proprietary Name
Tamoxifen Citrate
Substance Name
Tamoxifen Citrate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
TAMOXIFEN CITRATE 1 kg/kg
Usage Information
Tamoxifen is used to treat breast cancer. It is also used to reduce the chances of breast cancer in high-risk patients. This medication can block the growth of breast cancer. It works by interfering with the effects of estrogen in the breast tissue.

Regulatory & Marketing

Labeler Name
Chemische Fabrik Berg Gmbh
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-01-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65319-1051). Click a package code to view its specific billing and regulatory data.

65319-1051-1
1 kg in 1 DRUM
65319-1051-3
25 kg in 1 DRUM

* 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 65319-1051-2 identifies a specific commercial package of 10 kg in 1 drum of Tamoxifen Citrate (UNFINISHED drug), a bulk ingredient labeled by Chemische Fabrik Berg Gmbh. This powder is formulated for use and contains tamoxifen citrate 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 Chemische Fabrik Berg Gmbh on April 01, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tamoxifen is used to treat breast cancer. It is also used to reduce the chances of breast cancer in high-risk patients. This medication can block the growth of breast cancer. It works by interfering with the effects of estrogen in the breast tissue.

How is this Chemische Fabrik Berg Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65319105102. 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 (5-4-1)
65319-1051-2
11-Digit CMS (5-4-2)
65319-1051-02

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