Gyntima Menopausa Suppository
NDC Package 85401-022-26

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

Package Information

Gyntima Menopausa (sage, lactic acid, folic acid) suppositories is helps restore and maintain natural vaginal moisture levels, supporting comfort during menopause. This formulation utilizes a suppository delivery system. Marketed by Fytofontana Llc, this product is identified by NDC 85401-022.

Identification & Billing

NDC Package Code
85401-022-26
Package Description
2 BLISTER PACK in 1 BOX / 2 SUPPOSITORY in 1 BLISTER PACK
Product Code
85401-022
11-Digit Billing Format
85401002226

Clinical Specifications

Proprietary Name
Gyntima Menopausa
Non-Proprietary Name
Sage, Lactic Acid, Folic Acid
Substance Name
Folic Acid; Lactic Acid, Dl-; Sage
Dosage Form
Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Helps restore and maintain natural vaginal moisture levels, supporting comfort during menopause. Supports natural hydration and helps maintain the elasticity of vaginal tissues. Assists in relieving vaginal dryness, discomfort, itching, and sensitivity caused by hormonal changes. Designed to support the natural balance of the vaginal microbiome and mucosa.

Regulatory & Marketing

Labeler Name
Fytofontana Llc
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
08-24-2025
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 85401-022-26 identifies a specific commercial package of 2 blister pack in 1 box / 2 suppository in 1 blister pack of Gyntima Menopausa, a human over the counter drug labeled by Fytofontana Llc. This suppository is formulated for vaginal use and contains folic acid; lactic acid, dl-; sage 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 Fytofontana Llc on August 24, 2025. The current certification is valid through December 31, 2026.

How is this Fytofontana Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85401002226. 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)
85401-022-26
11-Digit CMS (5-4-2)
85401-0022-26

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