Diclofenac Sodium Tablet, Delayed Release
NDC Package 61145-101-06

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 tablets is diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. This formulation utilizes a tablet, delayed release delivery system. Marketed by Repharm Llc, this product is identified by NDC 61145-101 and is authorized under FDA application ANDA075185.

Identification & Billing

NDC Package Code
61145-101-06
Package Description
24 BOTTLE, PLASTIC in 1 BOX / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Product Code
61145-101
11-Digit Billing Format
61145010106
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
24 EA
RxNorm Crosswalk
  • RxCUI: 855906 - diclofenac sodium 50 MG Delayed Release Oral Tablet
  • RxCUI: 855926 - diclofenac sodium 75 MG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Diclofenac Sodium Delayed Release
Non-Proprietary Name
Diclofenac Sodium
Substance Name
Diclofenac Sodium
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)
DICLOFENAC SODIUM 50 mg/1
Pharmacologic Class
Usage Information
Diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). 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
Repharm Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA075185
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-27-2017
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 (61145-101). Click a package code to view its specific billing and regulatory data.

61145-101-09
24 BOTTLE, PLASTIC in 1 BOX / 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
61145-101-18
24 BOTTLE, PLASTIC in 1 BOX / 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC

* 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 61145-101-06 identifies a specific commercial package of 24 bottle, plastic in 1 box / 60 tablet, delayed release in 1 bottle, plastic of Diclofenac Sodium Delayed Release, a human prescription drug labeled by Repharm Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 24 billable units per package. This tablet, delayed release is formulated for oral use and contains diclofenac sodium 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 Repharm Llc on September 27, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). 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 Repharm Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61145010106. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 24 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 (5-3-2)
61145-101-06
11-Digit CMS (5-4-2)
61145-0101-06

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