Bio-sorb
NDC Package 51021-302-08

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Bio-sorb is diclofenac sodium is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Marketed by Sircle Laboratories, Llc, this product is identified by NDC 51021-302 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
51021-302-08
Package Description
237 mL in 1 BOTTLE, PUMP
Product Code
51021-302
11-Digit Billing Format
51021030208
RxNorm Crosswalk
  • RxCUI: 857700 - diclofenac sodium 1.5 % Topical Solution
  • RxCUI: 857700 - diclofenac sodium 15 MG/ML Topical Solution
  • RxCUI: 857700 - diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution
  • RxCUI: 857700 - diclofenac sodium 16.05 MG per 1 ML Topical Solution

Clinical Specifications

Proprietary Name
Bio-sorb
Dosage Form
-
Usage Information
Diclofenac sodium is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).

Regulatory & Marketing

Labeler Name
Sircle Laboratories, Llc
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
10-20-2018
Listing Expiration
12-31-2022
Exclude Flag
I
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 51021-302-08 identifies a specific commercial package of 237 ml in 1 bottle, pump of Bio-sorb, labeled by Sircle Laboratories, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sircle Laboratories, Llc on October 20, 2018. The current certification is valid through December 31, 2022.

How is this Sircle Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51021030208. 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)
51021-302-08
11-Digit CMS (5-4-2)
51021-0302-08

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