Deramsilkrx Anodynexa Pak
NDC Package 69329-310-00

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.

Deramsilkrx Anodynexa Pak is carefully consider the potential bene ts and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Marketed by Patchwerx Labs, Inc., this product is identified by NDC 69329-310 and is authorized under FDA application ANDA074514.

Identification & Billing

NDC Package Code
69329-310-00
Package Description
1 KIT in 1 PACKAGE * 1 BOTTLE, PLASTIC in 1 KIT / 60 TABLET in 1 BOTTLE, PLASTIC (53746-253-60) * 1 TUBE in 1 KIT / 237 mL in 1 TUBE (69329-323-01) * 1 BOTTLE, PLASTIC in 1 KIT / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0228-2551-06)
Product Code
69329-310
11-Digit Billing Format
69329031000
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Deramsilkrx Anodynexa Pak
Dosage Form
-
Usage Information
Carefully consider the potential bene ts 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).Diclofenac is indicated:For relief of the signs and symptoms of osteoarthritisFor relief of the signs and symptoms of rheumatoid arthritisFor acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis Ranitidine Tablets, USP are indicated in:Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with Ranitidine Tablets, USP 150 mg b.i.d.Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets, USP 150 mg q.i.d.Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.

Regulatory & Marketing

Labeler Name
Patchwerx Labs, Inc.
FDA Application #
ANDA074514
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-12-2015
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage
  • 69329 - Patchwerx Labs, Inc.
    • 69329-310 - Deramsilkrx Anodynexa Pak
      • 69329-310-00 - 1 KIT in 1 PACKAGE * 1 BOTTLE, PLASTIC in 1 KIT / 60 TABLET in 1 BOTTLE, PLASTIC (53746-253-60) * 1 TUBE in 1 KIT / 237 mL in 1 TUBE (69329-323-01) * 1 BOTTLE, PLASTIC in 1 KIT / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0228-2551-06)

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 69329-310-00 identifies a specific commercial package of 1 kit in 1 package * 1 bottle, plastic in 1 kit / 60 tablet in 1 bottle, plastic (53746-253-60) * 1 tube in 1 kit / 237 ml in 1 tube (69329-323-01) * 1 bottle, plastic in 1 kit / 60 tablet, delayed release in 1 bottle, plastic (0228-2551-06) of Deramsilkrx Anodynexa Pak, labeled by Patchwerx Labs, 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 Patchwerx Labs, Inc. on June 12, 2015. The current certification is valid through December 31, 2017.

How is this Patchwerx Labs, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69329031000. 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)
69329-310-00
11-Digit CMS (5-4-2)
69329-0310-00

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