Ketorolac Tromethamine
NDC Package 12634-809-71
Package Information
Ketorolac Tromethamine is ketorolac is used for the short-term treatment of moderate to severe pain. Marketed by Apotheca, Inc, this product is identified by NDC 12634-809 and is authorized under FDA application ANDA074754.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 12634 - Apotheca, Inc
- 12634-809 - Ketorolac Tromethamine
- 12634-809-71 - 30 TABLET in 1 BOTTLE
- 12634-809 - Ketorolac Tromethamine
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 (12634-809). 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 12634-809-71 identifies a specific commercial package of 30 tablet in 1 bottle of Ketorolac Tromethamine, 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 October 25, 2005. The current certification is valid through December 31, 2019.
What are the primary indications for this medication?
Ketorolac is used for the short-term treatment of moderate to severe pain. It is usually used before or after medical procedures or after surgery. Reducing pain helps you recover more comfortably so that you can return to your normal daily activities. This medication is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever. Ketorolac should not be used for mild or long-term painful conditions (such as arthritis).
How is this Apotheca, Inc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 12634080971. 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.
