Etonogestrel And Ethinyl Estradiol Insert, Extended Release
NDC Package 0093-7679-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Etonogestrel And Ethinyl Estradiol inserts is fOR VAGINAL USE ONLYEtonogestrel and ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy. This formulation utilizes a insert, extended release delivery system. Marketed by Teva Pharmaceuticals Usa, Inc., this product is identified by NDC 0093-7679 and is authorized under FDA application ANDA204305.

Identification & Billing

NDC Package Code
0093-7679-02
Package Description
3 POUCH in 1 CARTON / 21 d in 1 POUCH (0093-7679-01)
Product Code
11-Digit Billing Format
00093767902
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
Non-Proprietary Name
Etonogestrel And Ethinyl Estradiol
Substance Name
Ethinyl Estradiol; Etonogestrel
Dosage Form
Insert, Extended Release - A specially formulated and shaped non-encapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where the medication is released, generally for localized effects; the extended release preparation is designed to allow for a reduction in dosing frequency.
Administration Route
Vaginal - Administration into the vagina.
Usage Information
FOR VAGINAL USE ONLYEtonogestrel and ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy.

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204305
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-19-2021
End Marketing Date
07-31-2027
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 0093-7679-02 identifies a specific commercial package of 3 pouch in 1 carton / 21 d in 1 pouch (0093-7679-01) of Etonogestrel And Ethinyl Estradiol, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. This insert, extended release 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 Teva Pharmaceuticals Usa, Inc. on January 19, 2021.

How is this Teva Pharmaceuticals Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00093767902. 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 (4-4-2)
0093-7679-02
11-Digit CMS (5-4-2)
00093-7679-02

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