Breast Nodule Capsule
NDC Package 85631-010-01

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

Package Information

Breast Nodule capsules is dosage:For prevention: once per day,2 tablets per dosing.Patient with nodule: twice per day.2 tablets per dosing (doubled forsevere patient). This formulation utilizes a capsule delivery system. Marketed by Bispit Canada Ltd., this product is identified by NDC 85631-010.

Identification & Billing

NDC Package Code
85631-010-01
Package Description
60 CAPSULE in 1 BOTTLE / 1 g in 1 CAPSULE
Product Code
85631-010
11-Digit Billing Format
85631001001

Clinical Specifications

Proprietary Name
Breast Nodule
Non-Proprietary Name
Breast Nodule
Substance Name
Angelica Sinensis Root; Black Pepper; Citrus Medica Var. Sarcodactylis Whole; Crataegus Rivularis Whole; Curcuma Aromatica Root; Prunus Persica Seed; Rosa Rugosa Flower; Tangerine Peel; Taraxacum Officinale
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Dosage:For prevention: once per day,2 tablets per dosing.Patient with nodule: twice per day.2 tablets per dosing (doubled forsevere patient).

Regulatory & Marketing

Labeler Name
Bispit Canada Ltd.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
11-03-2025
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 85631-010-01 identifies a specific commercial package of 60 capsule in 1 bottle / 1 g in 1 capsule of Breast Nodule, a human over the counter drug labeled by Bispit Canada Ltd.. This capsule is formulated for oral use and contains angelica sinensis root; black pepper; citrus medica var. sarcodactylis whole; crataegus rivularis whole; curcuma aromatica root; prunus persica seed; rosa rugosa flower; tangerine peel; taraxacum officinale 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 Bispit Canada Ltd. on November 03, 2025. The current certification is valid through December 31, 2026.

How is this Bispit Canada Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85631001001. 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)
85631-010-01
11-Digit CMS (5-4-2)
85631-0010-01

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