Etodolac Tablet, Extended Release
NDC Package 51672-4053-2

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

Etodolac tablets is etodolac is used to relieve pain from various conditions. This formulation utilizes a tablet, extended release delivery system. Marketed by Taro Pharmaceuticals U.s.a., Inc., this product is identified by NDC 51672-4053 and is authorized under FDA application ANDA076174.

Identification & Billing

NDC Package Code
51672-4053-2
Package Description
500 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
51672-4053
11-Digit Billing Format
51672405302
RxNorm Crosswalk
  • RxCUI: 310245 - etodolac 400 MG 24HR Extended Release Oral Tablet
  • RxCUI: 310245 - 24 HR etodolac 400 MG Extended Release Oral Tablet
  • RxCUI: 310245 - etodolac 400 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 310247 - etodolac 600 MG 24HR Extended Release Oral Tablet
  • RxCUI: 310247 - 24 HR etodolac 600 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Etodolac
Non-Proprietary Name
Etodolac
Substance Name
Etodolac
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ETODOLAC 600 mg/1
Pharmacologic Class
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
Taro Pharmaceuticals U.s.a., Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076174
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-13-2003
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 (51672-4053). Click a package code to view its specific billing and regulatory data.

51672-4053-1
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
51672-4053-3
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE
51672-4053-4
60 TABLET, EXTENDED RELEASE in 1 BOTTLE
51672-4053-6
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
51672-4053-9
10 BLISTER PACK in 1 CARTON / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

* 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 51672-4053-2 identifies a specific commercial package of 500 tablet, extended release in 1 bottle of Etodolac, a human prescription drug labeled by Taro Pharmaceuticals U.s.a., Inc.. This tablet, extended release is formulated for oral use and contains etodolac 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 Taro Pharmaceuticals U.s.a., Inc. on March 13, 2003. The current certification is valid through December 31, 2026.

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 Taro Pharmaceuticals U.s.a., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672405302. 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 (5-4-1)
51672-4053-2
11-Digit CMS (5-4-2)
51672-4053-02

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