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  5. NDC Package Code: 58657-419-01 Esterified Estrogens And Methyltestosterone Full Strength

NDC Package 58657-419-01 Esterified Estrogens And Methyltestosterone Full Strength

Esterified Estrogens,Methyltestosterone Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
58657-419-01
Package Description:
100 TABLET in 1 BOTTLE
Product Code:
58657-419
Proprietary Name:
Esterified Estrogens And Methyltestosterone Full Strength
Non-Proprietary Name:
Esterified Estrogens, Methyltestosterone
Substance Name:
Estrogens, Esterified; Methyltestosterone
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).
11-Digit NDC Billing Format:
58657041901
NDC to 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
Product Type:
Human Prescription Drug
Labeler Name:
Method Pharmaceuticals, Llc
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Pharmacologic Class(es):
DEA Schedule:
Schedule III (CIII) Substances
Sample Package:
No
Marketing Category:
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date:
03-10-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 58657-419-01?

The NDC Packaged Code 58657-419-01 is assigned to a package of 100 tablet in 1 bottle of Esterified Estrogens And Methyltestosterone Full Strength, a human prescription drug labeled by Method Pharmaceuticals, Llc. The product's dosage form is tablet and is administered via oral form.

Is NDC 58657-419 included in the NDC Directory?

Yes, Esterified Estrogens And Methyltestosterone Full Strength with product code 58657-419 is active and included in the NDC Directory. The product was first marketed by Method Pharmaceuticals, Llc on March 10, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 58657-419-01?

The 11-digit format is 58657041901. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-258657-419-015-4-258657-0419-01