Diclofenac Sodium/misoprostol Tablet
NDC Package 42571-133-29

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 tablets is diclofenac is used to reduce pain, swelling, and joint stiffness from arthritis. This formulation utilizes a tablet delivery system. Marketed by Micro Labs Limited, this product is identified by NDC 42571-133 and is authorized under FDA application ANDA204355.

Identification & Billing

NDC Package Code
42571-133-29
Package Description
60 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Code
42571-133
11-Digit Billing Format
42571013329
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 Diclofenac-sodium-misoprostol
Non-Proprietary Name
Diclofenac Sodium/misoprostol
Substance Name
Diclofenac Sodium; Misoprostol
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Diclofenac is used to reduce pain, swelling, and joint stiffness from arthritis. Diclofenac is known as a nonsteroidal anti-inflammatory drug (NSAID). Misoprostol protects the stomach from diclofenac's irritating effects. This combination medication is used to treat arthritis in people at high risk of getting stomach/intestinal ulcers and complications from the ulcers (such as bleeding). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

Regulatory & Marketing

Labeler Name
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA204355
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42571-133). Click a package code to view its specific billing and regulatory data.

42571-133-30
30 TABLET in 1 BOTTLE
42571-133-60
60 TABLET in 1 BOTTLE
42571-133-90
90 TABLET 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 42571-133-29 identifies a specific commercial package of 60 blister pack in 1 carton / 10 tablet in 1 blister pack of Diclofenac Sodium/misoprostol Diclofenac-sodium-misoprostol, a human prescription drug labeled by Micro Labs Limited. This tablet 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 Micro Labs Limited on September 01, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Diclofenac is used to reduce pain, swelling, and joint stiffness from arthritis. Diclofenac is known as a nonsteroidal anti-inflammatory drug (NSAID). Misoprostol protects the stomach from diclofenac's irritating effects. This combination medication is used to treat arthritis in people at high risk of getting stomach/intestinal ulcers and complications from the ulcers (such as bleeding). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

How is this Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571013329. 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)
42571-133-29
11-Digit CMS (5-4-2)
42571-0133-29

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