Menotrophin Powder
NDC Package 76403-4002-0

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.

Menotrophin powders is a medication used to treat certain fertility problems in women. This formulation utilizes a powder delivery system. Marketed by Bsv Bioscience Gmbh, this product is identified by NDC 76403-4002.

Identification & Billing

NDC Package Code
76403-4002-0
Package Description
2000000 [iU] in 1 VIAL, GLASS
Product Code
76403-4002
11-Digit Billing Format
76403400200

Clinical Specifications

Proprietary Name
Menotrophin
Non-Proprietary Name
Menotrophin
Substance Name
Menotropins
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)
MENOTROPINS 2000000 [iU]/2000000[iU]
Usage Information
This medication is used to treat certain fertility problems in women. It provides follicle stimulating hormone (FSH) and luteinizing hormone (LH) that help healthy ovaries to make eggs. This medication is usually used in combination with another hormone (human chorionic gonadotropin-hCG) to help you become pregnant by bringing about the growth and release of a mature egg (ovulation). This medication is not recommended for women whose ovaries no longer make eggs properly (primary ovarian failure).

Regulatory & Marketing

Labeler Name
Bsv Bioscience Gmbh
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
12-05-2017
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 76403-4002-0 identifies a specific commercial package of 2000000 [iu] in 1 vial, glass of Menotrophin (UNFINISHED drug), a bulk ingredient labeled by Bsv Bioscience Gmbh. This powder is formulated for use and contains menotropins 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 Bsv Bioscience Gmbh on December 05, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain fertility problems in women. It provides follicle stimulating hormone (FSH) and luteinizing hormone (LH) that help healthy ovaries to make eggs. This medication is usually used in combination with another hormone (human chorionic gonadotropin-hCG) to help you become pregnant by bringing about the growth and release of a mature egg (ovulation). This medication is not recommended for women whose ovaries no longer make eggs properly (primary ovarian failure).

How is this Bsv Bioscience Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76403400200. 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)
76403-4002-0
11-Digit CMS (5-4-2)
76403-4002-00

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