Testopro Spray
NDC Package 43853-0035-1

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

Package Information

Testopro (avena sativa, damiana, hamamelis virginiana, korean ginseng, populus tremuloides, baryta carbonica, hepar suis, nuphar luteum, orchitinum suis, phosphoricum acidum, sabal serulata, selenium metallicum, testosterone, tribulus terrestris, horny goat weed, tongkat ali, fenugreek) sprays is classified as a

administered via oral route. This formulation utilizes a spray delivery system. Marketed by Problen, this product is identified by NDC 43853-0035.

Identification & Billing

NDC Package Code
43853-0035-1
Package Description
30 mL in 1 BOTTLE
Product Code
43853-0035
11-Digit Billing Format
43853003501

Clinical Specifications

Proprietary Name
Testopro
Non-Proprietary Name
Avena Sativa, Damiana, Hamamelis Virginiana, Korean Ginseng, Populus Tremuloides, Baryta Carbonica, Hepar Suis, Nuphar Luteum, Orchitinum Suis, Phosphoricum Acidum, Sabal Serulata, Selenium Metallicum, Testosterone, Tribulus Terrestris, Horny Goat Weed, Tongkat Ali, Fenugreek
Substance Name
Asian Ginseng; Avena Sativa Flowering Top; Barium Carbonate; Epimedium Grandiflorum Top; Eurycoma Longifolia Whole; Fenugreek Seed; Hamamelis Virginiana Root Bark/stem Bark; Nuphar Lutea Root; Phosphoric Acid; Populus Tremuloides Whole; Pork Liver; Saw Palmetto; Selenium; Sus Scrofa Testicle; Testosterone; Tribulus Terrestris Whole; Turnera Diffusa Leafy Twig
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
DEA Schedule
Schedule III (CIII) Substances

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
06-28-2017
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 43853-0035-1 identifies a specific commercial package of 30 ml in 1 bottle of Testopro, a human over the counter drug labeled by Problen. This spray is formulated for oral use and contains asian ginseng; avena sativa flowering top; barium carbonate; epimedium grandiflorum top; eurycoma longifolia whole; fenugreek seed; hamamelis virginiana root bark/stem bark; nuphar lutea root; phosphoric acid; populus tremuloides whole; pork liver; saw palmetto; selenium; sus scrofa testicle; testosterone; tribulus terrestris whole; turnera diffusa leafy twig 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 June 28, 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: 43853003501. 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)
43853-0035-1
11-Digit CMS (5-4-2)
43853-0035-01

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