Dinoprostone Powder
NDC Package 82231-104-01

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 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.

Dinoprostone powders is a medication used to help prepare your cervix (the lower opening of the womb) for labor and delivery. This formulation utilizes a powder delivery system. Marketed by Euroapi Hungary Ltd., this product is identified by NDC 82231-104.

Identification & Billing

NDC Package Code
82231-104-01
Package Description
100 g in 1 BOTTLE
Product Code
82231-104
11-Digit Billing Format
82231010401

Clinical Specifications

Proprietary Name
Dinoprostone
Non-Proprietary Name
Dinoprostone
Substance Name
Dinoprostone
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)
DINOPROSTONE 1 g/g
Usage Information
This medication is used to help prepare your cervix (the lower opening of the womb) for labor and delivery. It is used in women who are having a normal pregnancy and who are at or near their delivery due date. Dinoprostone is a natural substance that your body makes in preparation for labor. It relaxes and softens your cervix (cervical ripening) to allow the baby to pass through the birth canal during delivery.

Regulatory & Marketing

Labeler Name
Euroapi Hungary Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-28-2014
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 82231-104-01 identifies a specific commercial package of 100 g in 1 bottle of Dinoprostone (UNFINISHED drug), a bulk ingredient labeled by Euroapi Hungary Ltd.. This powder is formulated for use and contains dinoprostone 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 Euroapi Hungary Ltd. on October 28, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to help prepare your cervix (the lower opening of the womb) for labor and delivery. It is used in women who are having a normal pregnancy and who are at or near their delivery due date. Dinoprostone is a natural substance that your body makes in preparation for labor. It relaxes and softens your cervix (cervical ripening) to allow the baby to pass through the birth canal during delivery.

How is this Euroapi Hungary Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82231010401. 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)
82231-104-01
11-Digit CMS (5-4-2)
82231-0104-01

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