Diclofenac Potassium Tablet, Coated
NDC Package 55700-989-60

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Diclofenac Potassium tablets is diclofenac is used to relieve pain and swelling (inflammation) from various mild to moderate painful conditions. This formulation utilizes a tablet, coated delivery system. Marketed by Quality Care Products, Llc, this product is identified by NDC 55700-989 and is authorized under FDA application ANDA075229.

Identification & Billing

NDC Package Code
55700-989-60
Package Description
60 TABLET, COATED in 1 BOTTLE
Product Code
55700-989
11-Digit Billing Format
55700098960
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diclofenac Potassium
Non-Proprietary Name
Diclofenac Potassium
Substance Name
Diclofenac Potassium
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DICLOFENAC POTASSIUM 50 mg/1
Pharmacologic Class
Usage Information
Diclofenac is used to relieve pain and swelling (inflammation) from various mild to moderate painful conditions. It is used to treat muscle aches, backaches, dental pain, menstrual cramps, and sports injuries. It also reduces pain, swelling, 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
Quality Care Products, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA075229
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-22-2022
End Marketing Date
06-30-2026
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 55700-989-60 identifies a specific commercial package of 60 tablet, coated in 1 bottle of Diclofenac Potassium, a human prescription drug labeled by Quality Care Products, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet, coated is formulated for oral use and contains diclofenac potassium 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 Quality Care Products, Llc on November 22, 2022.

What are the primary indications for this medication?

Diclofenac is used to relieve pain and swelling (inflammation) from various mild to moderate painful conditions. It is used to treat muscle aches, backaches, dental pain, menstrual cramps, and sports injuries. It also reduces pain, swelling, 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 Quality Care Products, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55700098960. 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 (5-3-2)
55700-989-60
11-Digit CMS (5-4-2)
55700-0989-60

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