Drospirenone Powder
NDC Package 59057-014-00

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.

Drospirenone powders is a medication used to prevent pregnancy. This formulation utilizes a powder delivery system. Marketed by Sterling Chemical Malta Ltd, this product is identified by NDC 59057-014.

Identification & Billing

NDC Package Code
59057-014-00
Package Description
1 BAG in 1 DRUM / 20 kg in 1 BAG
Product Code
59057-014
11-Digit Billing Format
59057001400

Clinical Specifications

Proprietary Name
Drospirenone
Non-Proprietary Name
Drospirenone
Substance Name
Drospirenone
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)
DROSPIRENONE 1 kg/kg
Usage Information
This medication is used to prevent pregnancy. Drospirenone (a progestin) is a hormone that works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, and decrease your risk of ovarian cysts. Using this product does not protect you or your partner against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method (latex or polyurethane condom/dental dams) during all sexual activity.

Regulatory & Marketing

Labeler Name
Sterling Chemical Malta Ltd
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
05-12-2023
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 59057-014-00 identifies a specific commercial package of 1 bag in 1 drum / 20 kg in 1 bag of Drospirenone (UNFINISHED drug), a bulk ingredient labeled by Sterling Chemical Malta Ltd. This powder is formulated for use and contains drospirenone 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 Sterling Chemical Malta Ltd on May 12, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to prevent pregnancy. Drospirenone (a progestin) is a hormone that works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, and decrease your risk of ovarian cysts. Using this product does not protect you or your partner against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method (latex or polyurethane condom/dental dams) during all sexual activity.

How is this Sterling Chemical Malta Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59057001400. 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)
59057-014-00
11-Digit CMS (5-4-2)
59057-0014-00

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