Flexipak
NDC Package 69336-202-01

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.

Flexipak is carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Marketed by Sterling-knight Pharmaceuticals, Llc, this product is identified by NDC 69336-202 and is authorized under FDA application ANDA075185.

Identification & Billing

NDC Package Code
69336-202-01
Package Description
1 KIT in 1 CARTON * 60 TABLET, DELAYED RELEASE in 1 BOTTLE (61442-103-60) * 1 TUBE in 1 CARTON (0536-2525-25) / 60 g in 1 TUBE
Product Code
69336-202
11-Digit Billing Format
69336020201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Flexipak
Dosage Form
-
Usage Information
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac is indicated:For relief of the signs and symptoms of osteoarthritisFor relief of the signs and symptoms of rheumatoid arthritis For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

Regulatory & Marketing

Labeler Name
Sterling-knight Pharmaceuticals, Llc
FDA Application #
ANDA075185
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-19-2018
Listing Expiration
12-31-2019
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 69336-202-01 identifies a specific commercial package of 1 kit in 1 carton * 60 tablet, delayed release in 1 bottle (61442-103-60) * 1 tube in 1 carton (0536-2525-25) / 60 g in 1 tube of Flexipak, labeled by Sterling-knight Pharmaceuticals, 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 Sterling-knight Pharmaceuticals, Llc on January 19, 2018. The current certification is valid through December 31, 2019.

How is this Sterling-knight Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69336020201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
69336-202-01
11-Digit CMS (5-4-2)
69336-0202-01

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