Etodolac
NDC Package 61919-784-30

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Etodolac is used to relieve pain from various conditions. Marketed by Direct Rx, this product is identified by NDC 61919-784 and is authorized under FDA application ANDA076004.

Identification & Billing

NDC Package Code
61919-784-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
61919-784
11-Digit Billing Format
61919078430
RxNorm Crosswalk
RxCUI: 199390 - etodolac 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Etodolac
Dosage Form
-
Usage Information
Etodolac is used to relieve pain from various conditions. It also reduces pain, swelling, and joint stiffness from arthritis. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. 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
Direct Rx
FDA Application #
ANDA076004
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-21-2017
Listing Expiration
12-31-2022
Exclude Flag
I
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 61919-784-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Etodolac, labeled by Direct Rx. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Direct Rx on February 21, 2017. The current certification is valid through December 31, 2022.

What are the primary indications for this medication?

Etodolac is used to relieve pain from various conditions. It also reduces pain, swelling, and joint stiffness from arthritis. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. 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 Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61919078430. 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)
61919-784-30
11-Digit CMS (5-4-2)
61919-0784-30

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