Insulizen Capsule
NDC Package 80353-451-01

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

Package Information

Insulizen (insulin resistance reducer, insulin receptor restore, and blood sugar level balance) capsules is take two (2) capsules 1 hour before breakfast daily. This formulation utilizes a capsule delivery system. Marketed by Hcbiopharm Llc, this product is identified by NDC 80353-451.

Identification & Billing

NDC Package Code
80353-451-01
Package Description
1 BOTTLE in 1 BOX / 1 CAPSULE in 1 BOTTLE (80353-451-02) / 60 CAPSULE in 1 CAPSULE (80353-451-03)
Product Code
80353-451
11-Digit Billing Format
80353045101

Clinical Specifications

Proprietary Name
Insulizen
Non-Proprietary Name
Insulin Resistance Reducer, Insulin Receptor Restore, And Blood Sugar Level Balance
Substance Name
Lagerstroemia Speciosa Leaf; Morinda Citrifolia Fruit
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)
Usage Information
Take two (2) capsules 1 hour before breakfast daily.

Regulatory & Marketing

Labeler Name
Hcbiopharm 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
11-24-2021
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 80353-451-01 identifies a specific commercial package of 1 bottle in 1 box / 1 capsule in 1 bottle (80353-451-02) / 60 capsule in 1 capsule (80353-451-03) of Insulizen, a human over the counter drug labeled by Hcbiopharm Llc. This capsule is formulated for oral use and contains lagerstroemia speciosa leaf; morinda citrifolia fruit 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 Hcbiopharm Llc on November 24, 2021. The current certification is valid through December 31, 2027.

How is this Hcbiopharm Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80353045101. 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)
80353-451-01
11-Digit CMS (5-4-2)
80353-0451-01

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