Allium Cepa Globule
NDC Package 53645-1721-2

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

Package Information

Allium Cepa globules is place globules under tongue for 30 seconds. This formulation utilizes a globule delivery system. Marketed by True Botanica, Llc, this product is identified by NDC 53645-1721.

Identification & Billing

NDC Package Code
53645-1721-2
Package Description
23 g in 1 BOTTLE
Product Code
53645-1721
11-Digit Billing Format
53645172102

Clinical Specifications

Proprietary Name
Allium Cepa
Non-Proprietary Name
Allium Cepa
Substance Name
Allium Cepa Whole
Dosage Form
Globule - Also called pellets or pilules, are made of pure sucrose, lactose, or other polysaccharides. They are formed into small globular masses of various sizes, and are medicated by placing them in a vial and adding the liquid drug attenuation in the proportion not less than one percent (v/w). After shaking, the medicated globules are dried at temperatures not to exceed 40 degrees Centigrade.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ALLIUM CEPA WHOLE 30 [hp_X]/23g
Usage Information
Place globules under tongue for 30 seconds. Adults~3-5 globules 3 times a day. Children 2-12 years ~ 1-3 globules 3 times a day. Under 2 years, consult your doctor. Use until symptoms are relieved or as directed by your health care provider.

Regulatory & Marketing

Labeler Name
True Botanica, 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
12-30-2017
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 53645-1721-2 identifies a specific commercial package of 23 g in 1 bottle of Allium Cepa, a human over the counter drug labeled by True Botanica, Llc. This globule is formulated for oral use and contains allium cepa whole 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 True Botanica, Llc on December 30, 2017. The current certification is valid through December 31, 2026.

How is this True Botanica, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53645172102. 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)
53645-1721-2
11-Digit CMS (5-4-2)
53645-1721-02

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