Estradiol Valerate Powder
NDC Package 12866-1008-0

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 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.

Estradiol Valerate powders is a medication a female hormone (estrogen). This formulation utilizes a powder delivery system. Marketed by Bayer Ag, this product is identified by NDC 12866-1008.

Identification & Billing

NDC Package Code
12866-1008-0
Package Description
24.56 kg in 1 CONTAINER
Product Code
12866-1008
11-Digit Billing Format
12866100800

Clinical Specifications

Proprietary Name
Estradiol Valerate
Non-Proprietary Name
Estradiol Valerate
Substance Name
Estradiol Valerate
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)
ESTRADIOL VALERATE 1 kg/kg
Usage Information
This medication is a female hormone (estrogen). It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. This medication may also be used by women who are not able to produce enough estrogen (for example, due to hypogonadism, primary ovarian failure) and by men to treat prostate cancer.

Regulatory & Marketing

Labeler Name
Bayer Ag
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
05-10-2017
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 12866-1008-0 identifies a specific commercial package of 24.56 kg in 1 container of Estradiol Valerate (UNFINISHED drug), a bulk ingredient labeled by Bayer Ag. This powder is formulated for use and contains estradiol valerate 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 Bayer Ag on May 10, 2017. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is a female hormone (estrogen). It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. This medication may also be used by women who are not able to produce enough estrogen (for example, due to hypogonadism, primary ovarian failure) and by men to treat prostate cancer.

How is this Bayer Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12866100800. 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)
12866-1008-0
11-Digit CMS (5-4-2)
12866-1008-00

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