Guna-cell Solution/ Drops
NDC Package 17089-450-18

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

Package Information

Guna-cell (acetylcarnitine, l-ampc-alpha-lipoic ac-a-tocopherol-ascorbic acid-calc carb-citric ac-cobalamin-colchicum-conium-cupric sulf-herring sperm dna-ferrous fumarate-folic acid-fumaric acid-kali aspartate-mang phos-mang gluconate-mang phos ii-pyruvaldehyde-nat oxalaceticum-sodium pyruvate-niacin-pantothenic acid-ph-podophyllum peltatum-pyridoxine hydrochloride-riboflavin-saccharomyces cerevisiae rna-selenomethionine-succinic acid-sulfur-thiamine hydrochloride-zinc) solution/ dropses is take 15 minutes before mealsAdults and children 12 years and older    20 drops in a little water 2 times per dayChildren between 12 years and 6 years of age.    10 drops in a little water 2 times per dayChildren under 6 years     5 drops in a glass of water 2 times per day. This formulation utilizes a solution/ drops delivery system. Marketed by Guna Spa, this product is identified by NDC 17089-450.

Identification & Billing

NDC Package Code
17089-450-18
Package Description
1 BOTTLE, DROPPER in 1 BOX / 30 mL in 1 BOTTLE, DROPPER
Product Code
17089-450
11-Digit Billing Format
17089045018

Clinical Specifications

Proprietary Name
Guna-cell
Non-Proprietary Name
Acetylcarnitine, L-ampc-alpha-lipoic Ac-a-tocopherol-ascorbic Acid-calc Carb-citric Ac-cobalamin-colchicum-conium-cupric Sulf-herring Sperm Dna-ferrous Fumarate-folic Acid-fumaric Acid-kali Aspartate-mang Phos-mang Gluconate-mang Phos Ii-pyruvaldehyde-nat Oxalaceticum-sodium Pyruvate-niacin-pantothenic Acid-ph-podophyllum Peltatum-pyridoxine Hydrochloride-riboflavin-saccharomyces Cerevisiae Rna-selenomethionine-succinic Acid-sulfur-thiamine Hydrochloride-zinc
Substance Name
.alpha.-lipoic Acid; .alpha.-tocopherol Acetate, Dl-; Acetylcarnitine; Adenosine Cyclic Phosphate; Ascorbic Acid; Calcium Carbonate; Citric Acid Monohydrate; Cobalamin; Colchicum Autumnale Bulb; Conium Maculatum Flowering Top; Cupric Sulfate; Ferrous Fumarate; Folic Acid; Fumaric Acid; Herring Sperm Dna; Magnesium Phosphate, Tribasic, Pentahydrate; Manganese Gluconate; Manganese Phosphate, Dibasic; Niacin; Pantothenic Acid; Phosphorus; Podophyllum Peltatum Root; Potassium Aspartate; Pyridoxine Hydrochloride; Pyruvaldehyde; Riboflavin; Saccharomyces Cerevisiae Rna; Selenomethionine; Sodium Diethyl Oxalacetate; Sodium Pyruvate; Succinic Acid; Sulfur; Thiamine Hydrochloride; Zinc
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Take 15 minutes before mealsAdults and children 12 years and older    20 drops in a little water 2 times per dayChildren between 12 years and 6 years of age.    10 drops in a little water 2 times per dayChildren under 6 years     5 drops in a glass of water 2 times per day

Regulatory & Marketing

Labeler Name
Guna Spa
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
05-27-2010
Listing Expiration
12-31-2027
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 17089-450-18 identifies a specific commercial package of 1 bottle, dropper in 1 box / 30 ml in 1 bottle, dropper of Guna-cell, a human over the counter drug labeled by Guna Spa. This solution/ drops is formulated for oral use and contains .alpha.-lipoic acid; .alpha.-tocopherol acetate, dl-; acetylcarnitine; adenosine cyclic phosphate; ascorbic acid; calcium carbonate; citric acid monohydrate; cobalamin; colchicum autumnale bulb; conium maculatum flowering top; cupric sulfate; ferrous fumarate; folic acid; fumaric acid; herring sperm dna; magnesium phosphate, tribasic, pentahydrate; manganese gluconate; manganese phosphate, dibasic; niacin; pantothenic acid; phosphorus; podophyllum peltatum root; potassium aspartate; pyridoxine hydrochloride; pyruvaldehyde; riboflavin; saccharomyces cerevisiae rna; selenomethionine; sodium diethyl oxalacetate; sodium pyruvate; succinic acid; sulfur; thiamine hydrochloride; zinc 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 Guna Spa on May 27, 2010. The current certification is valid through December 31, 2027.

How is this Guna Spa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17089045018. 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)
17089-450-18
11-Digit CMS (5-4-2)
17089-0450-18

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