Esterified Estrogens And Methyltestosterone
NDC Package 66576-283-01

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 inactivated by the FDA.

Esterified Estrogens And Methyltestosterone is fULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. Marketed by Syntho Pharmaceuticals, Inc., this product is identified by NDC 66576-283.

Identification & Billing

NDC Package Code
66576-283-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
66576-283
11-Digit Billing Format
66576028301
RxNorm Crosswalk
  • RxCUI: 197670 - estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral Tablet
  • RxCUI: 197670 - estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral Tablet
  • RxCUI: 197670 - EEMT DS Oral Tablet
  • RxCUI: 238006 - estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral Tablet
  • RxCUI: 238006 - estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Esterified Estrogens And Methyltestosterone
Dosage Form
-
Usage Information
ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).

Regulatory & Marketing

Labeler Name
Syntho Pharmaceuticals, Inc.
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
12-02-2022
Listing Expiration
12-31-2023
Exclude Flag
I
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 66576-283-01 identifies a specific commercial package of 100 tablet in 1 bottle of Esterified Estrogens And Methyltestosterone, labeled by Syntho Pharmaceuticals, 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 Syntho Pharmaceuticals, Inc. on December 02, 2022. The current certification is valid through December 31, 2023.

How is this Syntho Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66576028301. 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)
66576-283-01
11-Digit CMS (5-4-2)
66576-0283-01

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