Etonogestrel Implant
NDC Package 71161-147-01

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 implants is a medication a small, thin plastic rod that is inserted under the skin to prevent pregnancy. This formulation utilizes a implant delivery system. Marketed by Synergy Health Ast, Llc, this product is identified by NDC 71161-147.

Identification & Billing

NDC Package Code
71161-147-01
Package Description
1 BLISTER PACK in 1 CARTON / 1 IMPLANT in 1 BLISTER PACK
Product Code
71161-147
11-Digit Billing Format
71161014701

Clinical Specifications

Proprietary Name
Etonogestrel
Non-Proprietary Name
Etonogestrel
Substance Name
Etonogestrel
Dosage Form
Implant - A material containing drug intended to be inserted securely of deeply in a living site for growth, slow release, or formation of an organic union.
Active Ingredient(s)
ETONOGESTREL 68 mg/1
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
Synergy Health Ast, Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
06-01-2021
Listing Expiration
12-31-2027
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 71161-147-01 identifies a specific commercial package of 1 blister pack in 1 carton / 1 implant in 1 blister pack of Etonogestrel (UNFINISHED drug), drug for further processing labeled by Synergy Health Ast, Llc. This implant 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 Synergy Health Ast, Llc on June 01, 2021. The current certification is valid through December 31, 2027.

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 Synergy Health Ast, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71161014701. 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)
71161-147-01
11-Digit CMS (5-4-2)
71161-0147-01

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