Esterified Estrogens And Methyltestosterone Tablet
NDC Package 84346-450-01

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

Package Information

Esterified Estrogens And Methyltestosterone (esterified estrogens, methyltestosterone) tablets is estrogens should not be used in women with any of the following conditions:1. This formulation utilizes a tablet delivery system. Marketed by Status Projects Private Limited, this product is identified by NDC 84346-450.

Identification & Billing

NDC Package Code
84346-450-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
84346-450
11-Digit Billing Format
84346045001
RxNorm Crosswalk
  • 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
  • RxCUI: 238006 - EEMT HS Oral Tablet

Clinical Specifications

Proprietary Name
Esterified Estrogens And Methyltestosterone
Non-Proprietary Name
Esterified Estrogens, Methyltestosterone
Substance Name
Estrogens, Esterified; Methyltestosterone
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Estrogens should not be used in women with any of the following conditions:1. Known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease.2. Known or suspected estrogen-dependent neoplasia.3. Known or suspected pregnancy.4. Undiagnosed abnormal genital bleeding.5. Active thrombophlebitis or thromboembolic disorders.6. A past history of thrombophlebitis, thrombosis, or thromboembolic disorders associated with previous estrogen use (except when in treatment of breast malignancy).Methyltestosterone should not be used in:1. The presence of severe liver damage.2. Pregnancy and in breast-feeding mothers because of the possibility of masculinization of the female fetus or breast-fed infant.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Status Projects Private Limited
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
04-20-2024
Listing Expiration
12-31-2027
Exclude Flag
N
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 84346-450-01 identifies a specific commercial package of 100 tablet in 1 bottle of Esterified Estrogens And Methyltestosterone, a human prescription drug labeled by Status Projects Private Limited. This tablet is formulated for oral use and contains estrogens, esterified; methyltestosterone 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 Status Projects Private Limited on April 20, 2024. The current certification is valid through December 31, 2027.

How is this Status Projects Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84346045001. 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)
84346-450-01
11-Digit CMS (5-4-2)
84346-0450-01

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