Methylergometrine Maleate Powder
NDC Package 84644-021-00

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.

Methylergometrine Maleate powders is a medication used after childbirth to help stop bleeding from the uterus. This formulation utilizes a powder delivery system. Marketed by Tapi Czech Industries S.r.o., this product is identified by NDC 84644-021.

Identification & Billing

NDC Package Code
84644-021-00
Package Description
1 kg in 1 CARTON
Product Code
84644-021
11-Digit Billing Format
84644002100

Clinical Specifications

Proprietary Name
Methylergometrine Maleate
Non-Proprietary Name
Methylergometrine Maleate
Substance Name
Methylergonovine Maleate
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)
METHYLERGONOVINE MALEATE 100 kg/100kg
Usage Information
This medication is used after childbirth to help stop bleeding from the uterus. Methylergonovine belongs to a class of drugs known as ergot alkaloids. It works by increasing the rate and strength of contractions and the stiffness of the uterus muscles. These effects help to decrease bleeding.

Regulatory & Marketing

Labeler Name
Tapi Czech Industries S.r.o.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
06-22-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 84644-021-00 identifies a specific commercial package of 1 kg in 1 carton of Methylergometrine Maleate (UNFINISHED drug), a bulk ingredient labeled by Tapi Czech Industries S.r.o.. This powder is formulated for use and contains methylergonovine maleate 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 Tapi Czech Industries S.r.o. on June 22, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used after childbirth to help stop bleeding from the uterus. Methylergonovine belongs to a class of drugs known as ergot alkaloids. It works by increasing the rate and strength of contractions and the stiffness of the uterus muscles. These effects help to decrease bleeding.

How is this Tapi Czech Industries S.r.o. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84644002100. 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)
84644-021-00
11-Digit CMS (5-4-2)
84644-0021-00

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