Gynestat Liquid
NDC Package 44911-0716-1

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

Package Information

Gynestat (cimicifuga racemosa, eucalyptus globulus, argentum nitricum, aurum muriaticum natronatum, borax, calcarea carbonica, kali bichromicum, kreosotum, lilium tigrinum, mercurius solubilis, pulsatilla (pratensis), sepia, staphysagria, thuja occidentalis) liquids is • Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. This formulation utilizes a liquid delivery system. Marketed by Energique, Inc., this product is identified by NDC 44911-0716.

Identification & Billing

NDC Package Code
44911-0716-1
Package Description
30 mL in 1 BOTTLE, DROPPER
Product Code
44911-0716
11-Digit Billing Format
44911071601

Clinical Specifications

Proprietary Name
Gynestat
Non-Proprietary Name
Cimicifuga Racemosa, Eucalyptus Globulus, Argentum Nitricum, Aurum Muriaticum Natronatum, Borax, Calcarea Carbonica, Kali Bichromicum, Kreosotum, Lilium Tigrinum, Mercurius Solubilis, Pulsatilla (pratensis), Sepia, Staphysagria, Thuja Occidentalis
Substance Name
Black Cohosh; Delphinium Staphisagria Seed; Eucalyptus Globulus Leaf; Lilium Lancifolium Whole Flowering; Mercurius Solubilis; Oyster Shell Calcium Carbonate, Crude; Potassium Dichromate; Pulsatilla Pratensis Whole; Sepia Officinalis Juice; Silver Nitrate; Sodium Borate; Sodium Tetrachloroaurate; Thuja Occidentalis Leafy Twig; Wood Creosote
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
• Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. • Consult a physician for use in children under 12 years of age.

Regulatory & Marketing

Labeler Name
Energique, Inc.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
08-02-2024
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 44911-0716-1 identifies a specific commercial package of 30 ml in 1 bottle, dropper of Gynestat, a human over the counter drug labeled by Energique, Inc.. This liquid is formulated for oral use and contains black cohosh; delphinium staphisagria seed; eucalyptus globulus leaf; lilium lancifolium whole flowering; mercurius solubilis; oyster shell calcium carbonate, crude; potassium dichromate; pulsatilla pratensis whole; sepia officinalis juice; silver nitrate; sodium borate; sodium tetrachloroaurate; thuja occidentalis leafy twig; wood creosote 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 Energique, Inc. on August 02, 2024. The current certification is valid through December 31, 2026.

How is this Energique, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44911071601. 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 (5-4-1)
44911-0716-1
11-Digit CMS (5-4-2)
44911-0716-01

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