Diclofenac Sodium Misoprostol Tablet, Delayed Release
NDC Package 75834-264-90

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

Package Information

Diclofenac Sodium Misoprostol (diclofenac sodium and misoprostol) tablets is diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. This formulation utilizes a tablet, delayed release delivery system. Marketed by Nivagen Pharmaceuticals, Inc., this product is identified by NDC 75834-264 and is authorized under FDA application ANDA205143.

Identification & Billing

NDC Package Code
75834-264-90
Package Description
90 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
75834-264
11-Digit Billing Format
75834026490
RxNorm Crosswalk
  • RxCUI: 1359105 - diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet
  • RxCUI: 1359105 - diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet
  • RxCUI: 1359105 - diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet
  • RxCUI: 1359105 - diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral Tablet
  • RxCUI: 857706 - diclofenac sodium 50 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Diclofenac Sodium Misoprostol
Non-Proprietary Name
Diclofenac Sodium And Misoprostol
Substance Name
Diclofenac Sodium; Misoprostol
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].

Regulatory & Marketing

Labeler Name
Nivagen Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA205143
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-15-2021
Listing Expiration
12-31-2027
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (75834-264). Click a package code to view its specific billing and regulatory data.

75834-264-60
60 TABLET, DELAYED RELEASE in 1 BOTTLE

* 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 75834-264-90 identifies a specific commercial package of 90 tablet, delayed release in 1 bottle of Diclofenac Sodium Misoprostol, a human prescription drug labeled by Nivagen Pharmaceuticals, Inc.. This tablet, delayed release is formulated for oral use and contains diclofenac sodium; misoprostol as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Nivagen Pharmaceuticals, Inc. on July 15, 2021. The current certification is valid through December 31, 2027.

How is this Nivagen Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75834026490. 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)
75834-264-90
11-Digit CMS (5-4-2)
75834-0264-90

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