Odynia-u
NDC Package 69647-003-01

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.

Odynia-u is uses temporarily relieves minor aches and pains associated with:  -arthritis  -simple backache --bursitis  --tendonitis--muscle strains --sprains  --bruises  --cramps. Marketed by Ursh Pharmaceutical Inc., this product is identified by NDC 69647-003 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
69647-003-01
Package Description
15 PATCH in 1 BOX / 10 g in 1 PATCH
Product Code
69647-003
11-Digit Billing Format
69647000301
RxNorm Crosswalk
  • RxCUI: 1605695 - Capsicum extract 0.03 % / lidocaine 4 % Medicated Patch
  • RxCUI: 1605695 - Capsicum extract 0.0003 MG/MG / lidocaine 0.04 MG/MG Medicated Patch

Clinical Specifications

Proprietary Name
Odynia-u
Dosage Form
-
Usage Information
Uses temporarily relieves minor aches and pains associated with:  -arthritis  -simple backache --bursitis  --tendonitis--muscle strains --sprains  --bruises  --cramps

Regulatory & Marketing

Labeler Name
Ursh Pharmaceutical Inc.
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
03-12-2015
Listing Expiration
12-31-2017
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 69647-003-01 identifies a specific commercial package of 15 patch in 1 box / 10 g in 1 patch of Odynia-u, labeled by Ursh Pharmaceutical Inc.. 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 Ursh Pharmaceutical Inc. on March 12, 2015. The current certification is valid through December 31, 2017.

How is this Ursh Pharmaceutical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69647000301. 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)
69647-003-01
11-Digit CMS (5-4-2)
69647-0003-01

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