Paingo Kft
NDC Package 69837-100-01

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.

Paingo Kft is a . Marketed by International Brand Management, Llc, this product is identified by NDC 69837-100 and is authorized under FDA application ANDA076453.

Identification & Billing

NDC Package Code
69837-100-01
Package Description
1 KIT in 1 KIT * 3 TUBE in 1 KIT / 30 g in 1 TUBE (0168-0357-30) * 1 CARTON in 1 KIT / 1 TUBE in 1 CARTON (69837-019-01) / 118 g in 1 TUBE (69837-019-02)
Product Code
69837-100
11-Digit Billing Format
69837010001
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 197877 - lidocaine 2.5 % / prilocaine 2.5 % Topical Cream
  • RxCUI: 197877 - lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical Cream
  • RxCUI: 311500 - menthol 10 % / methyl salicylate 30 % Topical Cream
  • RxCUI: 311500 - menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical Cream

Clinical Specifications

Proprietary Name
Paingo Kft
Dosage Form
-

Regulatory & Marketing

Labeler Name
International Brand Management, Llc
FDA Application #
ANDA076453
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-26-2017
Listing Expiration
12-31-2018
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 69837-100-01 identifies a specific commercial package of 1 kit in 1 kit * 3 tube in 1 kit / 30 g in 1 tube (0168-0357-30) * 1 carton in 1 kit / 1 tube in 1 carton (69837-019-01) / 118 g in 1 tube (69837-019-02) of Paingo Kft, labeled by International Brand Management, 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 International Brand Management, Llc on January 26, 2017. The current certification is valid through December 31, 2018.

How is this International Brand Management, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69837010001. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
69837-100-01
11-Digit CMS (5-4-2)
69837-0100-01

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