Annovera Ring
NDC Package 68308-752-01

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

Package Information

Annovera (segesterone acetate and ethinyl estradiol) rings is aNNOVERA is indicated for use by females of reproductive potential to prevent pregnancy. This formulation utilizes a ring delivery system. Marketed by Mayne Pharma, this product is identified by NDC 68308-752 and is authorized under FDA application NDA209627.

Identification & Billing

NDC Package Code
68308-752-01
Package Description
1 POUCH in 1 CARTON / 30 RING in 1 POUCH
Product Code
68308-752
11-Digit Billing Format
68308075201
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: 2055983 - segesterone acetate 0.15 MG / ethinyl estradiol 0.013 MG per 24HR One Year Vaginal System
  • RxCUI: 2055983 - 273 DAY ethinyl estradiol 0.000542 MG/HR / segesterone acetate 0.00625 MG/HR Vaginal System
  • RxCUI: 2055983 - ethinyl estradiol 0.013 MG / segesterone acetate 0.15 MG per 24HR 273 Day Vaginal System
  • RxCUI: 2055989 - Annovera 0.15 MG / 0.013 MG per 24HR One Year Vaginal System
  • RxCUI: 2055989 - 273 DAY ethinyl estradiol 0.000542 MG/HR / segesterone acetate 0.00625 MG/HR Vaginal System [Annovera]

Clinical Specifications

Proprietary Name
Annovera
Non-Proprietary Name
Segesterone Acetate And Ethinyl Estradiol
Substance Name
Ethinyl Estradiol; Segesterone Acetate
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
ANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy.

Regulatory & Marketing

Labeler Name
Mayne Pharma
Product Type
Human Prescription Drug
FDA Application #
NDA209627
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-16-2024
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 68308-752-01 identifies a specific commercial package of 1 pouch in 1 carton / 30 ring in 1 pouch of Annovera, a human prescription drug labeled by Mayne Pharma. This ring is formulated for vaginal use and contains ethinyl estradiol; segesterone acetate 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 Mayne Pharma on August 16, 2024. The current certification is valid through December 31, 2026.

How is this Mayne Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68308075201. 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)
68308-752-01
11-Digit CMS (5-4-2)
68308-0752-01

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