Indomethacin Er
NDC Package 12634-160-71
Package Information
Indomethacin Er is indomethacin is used to relieve pain, swelling, and joint stiffness caused by arthritis, bursitis, and tendonitis. Marketed by Apotheca, Inc., this product is identified by NDC 12634-160 and is authorized under FDA application ANDA079175.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 12634 - Apotheca, Inc.
- 12634-160 - Indomethacin Er
- 12634-160-71 - 30 CAPSULE in 1 BOTTLE, PLASTIC
- 12634-160 - Indomethacin Er
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 (12634-160). Click a package code to view its specific billing and regulatory data.
* 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 12634-160-71 identifies a specific commercial package of 30 capsule in 1 bottle, plastic of Indomethacin Er, labeled by Apotheca, Inc.. 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 Apotheca, Inc. on March 04, 2010. The current certification is valid through December 31, 2017.
What are the primary indications for this medication?
Indomethacin is used to relieve pain, swelling, and joint stiffness caused by arthritis, bursitis, and tendonitis. Reducing these symptoms helps you do more of your normal daily activities. The sustained release capsule does not relieve pain quickly. Therefore, do not use it for sudden gout attacks. 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 Apotheca, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 12634016071. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
