Dinoprostone Powder
NDC Package 40016-012-01

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 Ys Life Science Co., Ltd., this product is identified by NDC 40016-012.

Identification & Billing

NDC Package Code
40016-012-01
Package Description
15 g in 1 VIAL, GLASS
Product Code
40016-012
11-Digit Billing Format
40016001201

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
Ys Life Science Co., Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-18-2021
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 40016-012-01 identifies a specific commercial package of 15 g in 1 vial, glass of Dinoprostone (UNFINISHED drug), a bulk ingredient labeled by Ys Life Science Co., 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 Ys Life Science Co., Ltd. on February 18, 2021. 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 Ys Life Science Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 40016001201. 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)
40016-012-01
11-Digit CMS (5-4-2)
40016-0012-01

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