Etonogestrel Tablet
NDC Package 49803-012-01

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.

Etonogestrel tablets is a medication a small, thin plastic rod that is inserted under the skin to prevent pregnancy. This formulation utilizes a tablet delivery system. Marketed by Steroid S.p.a., this product is identified by NDC 49803-012.

Identification & Billing

NDC Package Code
49803-012-01
Package Description
1 BAG in 1 DRUM / 25000 g in 1 BAG
Product Code
49803-012
11-Digit Billing Format
49803001201

Clinical Specifications

Proprietary Name
Etonogestrel
Non-Proprietary Name
Etonogestrel
Substance Name
Etonogestrel
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Active Ingredient(s)
ETONOGESTREL 25000 g/25000g
Usage Information
This product is a small, thin plastic rod that is inserted under the skin to prevent pregnancy. The rod slowly releases etonogestrel into the body over a 3-year period. Etonogestrel is similar to a natural hormone made in your body. It 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. This product does not contain any estrogen. This medication may not work as well in women who are very overweight or those taking certain drugs. (See also Drug Interactions section.) Discuss your birth control options with your doctor. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Regulatory & Marketing

Labeler Name
Steroid S.p.a.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-22-2024
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 49803-012-01 identifies a specific commercial package of 1 bag in 1 drum / 25000 g in 1 bag of Etonogestrel (UNFINISHED drug), a bulk ingredient labeled by Steroid S.p.a.. This tablet is formulated for use and contains etonogestrel 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 Steroid S.p.a. on January 22, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is a small, thin plastic rod that is inserted under the skin to prevent pregnancy. The rod slowly releases etonogestrel into the body over a 3-year period. Etonogestrel is similar to a natural hormone made in your body. It 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. This product does not contain any estrogen. This medication may not work as well in women who are very overweight or those taking certain drugs. (See also Drug Interactions section.) Discuss your birth control options with your doctor. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

How is this Steroid S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49803001201. 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)
49803-012-01
11-Digit CMS (5-4-2)
49803-0012-01

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