Estrogen And Progesterone Spray
NDC Package 43853-0017-2

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

Package Information

Estrogen And Progesterone (agnus castus, angelica sinensis, apis mellifica, arnica montana, cimicifuga racemosa, estradiol, estriol, folliculinum, galium aparine, glycyrrhiza glabra, korean ginseng, oophorinum (suis), progesterone, sepia, thuja occidentalis, viscum album) sprays is temporarily supports the body to rebalance estrogen output. This formulation utilizes a spray delivery system. Marketed by Problen, this product is identified by NDC 43853-0017.

Identification & Billing

NDC Package Code
43853-0017-2
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 30 mL in 1 BOTTLE, SPRAY (43853-0017-1)
Product Code
43853-0017
11-Digit Billing Format
43853001702

Clinical Specifications

Proprietary Name
Estrogen And Progesterone
Non-Proprietary Name
Agnus Castus, Angelica Sinensis, Apis Mellifica, Arnica Montana, Cimicifuga Racemosa, Estradiol, Estriol, Folliculinum, Galium Aparine, Glycyrrhiza Glabra, Korean Ginseng, Oophorinum (suis), Progesterone, Sepia, Thuja Occidentalis, Viscum Album
Substance Name
Angelica Sinensis Root; Apis Mellifera; Arnica Montana; Asian Ginseng; Black Cohosh; Chaste Tree; Estradiol; Estriol; Estrone; Galium Aparine; Glycyrrhiza Glabra; Progesterone; Sepia Officinalis Juice; Sus Scrofa Ovary; Thuja Occidentalis Leafy Twig; Viscum Album Fruiting Top
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Temporarily supports the body to rebalance estrogen output.  Symptoms may include: mood swings, hot flashes, irritability, lack of energy. Temporarily supports the body to rebalance estrogen output. Symptoms may include: mood swings, hot flashes, irritability, lack of energy.

Regulatory & Marketing

Labeler Name
Problen
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
01-12-2017
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 43853-0017-2 identifies a specific commercial package of 1 bottle, spray in 1 carton / 30 ml in 1 bottle, spray (43853-0017-1) of Estrogen And Progesterone, a human over the counter drug labeled by Problen. This spray is formulated for oral use and contains angelica sinensis root; apis mellifera; arnica montana; asian ginseng; black cohosh; chaste tree; estradiol; estriol; estrone; galium aparine; glycyrrhiza glabra; progesterone; sepia officinalis juice; sus scrofa ovary; thuja occidentalis leafy twig; viscum album fruiting top 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 Problen on January 12, 2017. The current certification is valid through December 31, 2026.

How is this Problen product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43853001702. 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)
43853-0017-2
11-Digit CMS (5-4-2)
43853-0017-02

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