Nexplanon Implant
NDC Package 78206-145-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Nexplanon (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 Organon Llc, this product is identified by NDC 78206-145 and is authorized under FDA application NDA021529.

Identification & Billing

NDC Package Code
78206-145-01
Package Description
1 BLISTER PACK in 1 CARTON / 1 IMPLANT in 1 BLISTER PACK
Product Code
78206-145
11-Digit Billing Format
78206014501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nexplanon
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.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
ETONOGESTREL 68 mg/1
Pharmacologic Class
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
Organon Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021529
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-01-2021
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

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 78206-145-01 identifies a specific commercial package of 1 blister pack in 1 carton / 1 implant in 1 blister pack of Nexplanon, a human prescription drug labeled by Organon Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This implant is formulated for subcutaneous 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 Organon 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 Organon Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78206014501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
78206-145-01
11-Digit CMS (5-4-2)
78206-0145-01

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