Etonogestrel And Ethinyl Estradiol Vaginal Ring
NDC Package 42291-478-03

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

Package Information

Etonogestrel And Ethinyl Estradiol Vaginal rings is fOR VAGINAL USE ONLY Etonogestrel and ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy. This formulation utilizes a ring delivery system. Marketed by Avkare, this product is identified by NDC 42291-478 and is authorized under FDA application ANDA211157.

Identification & Billing

NDC Package Code
42291-478-03
Package Description
3 POUCH in 1 CARTON / 21 d in 1 POUCH (42291-478-11)
Product Code
42291-478
11-Digit Billing Format
42291047803
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1367436 - etonogestrel 0.12 MG / ethinyl estradiol 0.015 MG per 24HR 3 Week Vaginal System
  • RxCUI: 1367436 - 21 DAY ethinyl estradiol 0.000625 MG/HR / etonogestrel 0.005 MG/HR Vaginal System
  • RxCUI: 1367436 - ethinyl estradiol 0.015 MG / etonogestrel 0.12 MG per 24HR 3 Week Vaginal System
  • RxCUI: 1367436 - ethinyl estradiol 15 MCG / etonogestrel 120 MCG per 24HR 3 Week Vaginal System

Clinical Specifications

Proprietary Name
Etonogestrel And Ethinyl Estradiol Vaginal
Non-Proprietary Name
Etonogestrel And Ethinyl Estradiol Vaginal
Substance Name
Ethinyl Estradiol; Etonogestrel
Dosage Form
Ring - A small circular object with a vacant circular center that is usually intended to be placed in the body by special inserters, where the medication is released, generally for localized effects.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
Pharmacologic Class
Usage Information
FOR VAGINAL USE ONLY Etonogestrel and ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy.

Regulatory & Marketing

Labeler Name
Avkare
Product Type
Human Prescription Drug
FDA Application #
ANDA211157
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-21-2023
Listing Expiration
12-31-2026
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 42291-478-03 identifies a specific commercial package of 3 pouch in 1 carton / 21 d in 1 pouch (42291-478-11) of Etonogestrel And Ethinyl Estradiol Vaginal, a human prescription drug labeled by Avkare. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This ring is formulated for vaginal use and contains ethinyl estradiol; 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 Avkare on September 21, 2023. The current certification is valid through December 31, 2026.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291047803. 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)
42291-478-03
11-Digit CMS (5-4-2)
42291-0478-03

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