Arthrotec Tablet, Film Coated
NDC Package 0025-1421-60

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

Package Information

Arthrotec (diclofenac sodium and misoprostol) tablets is aRTHROTEC is 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, film coated delivery system. Marketed by Pfizer Laboratories Div Pfizer Inc, this product is identified by NDC 0025-1421 and is authorized under FDA application NDA020607.

Identification & Billing

NDC Package Code
0025-1421-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
0025-1421
11-Digit Billing Format
00025142160
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
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: 1359107 - Arthrotec 50 MG / 200 MCG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Arthrotec
Non-Proprietary Name
Diclofenac Sodium And Misoprostol
Substance Name
Diclofenac Sodium; Misoprostol
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
ARTHROTEC is 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
Pfizer Laboratories Div Pfizer Inc
Product Type
Human Prescription Drug
FDA Application #
NDA020607
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-24-1997
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0025-1421-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Arthrotec, a human prescription drug labeled by Pfizer Laboratories Div Pfizer Inc. This tablet, film coated 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 Pfizer Laboratories Div Pfizer Inc on December 24, 1997. The current certification is valid through December 31, 2026.

How is this Pfizer Laboratories Div Pfizer Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00025142160. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. 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 (4-4-2)
0025-1421-60
11-Digit CMS (5-4-2)
00025-1421-60

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