Ultram
NDC Package 0045-0659-10
Package Information
Ultram is see also Warning section. Marketed by Ortho-mcneil-janssen Pharmaceuticals, Inc., this product is identified by NDC 0045-0659 and is authorized under FDA application NDA020281.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0045 - Ortho-mcneil-janssen Pharmaceuticals, Inc.
- 0045-0659 - Ultram
- 0045-0659-10 - 10 BLISTER PACK in 1 BOX / 10 TABLET, COATED in 1 BLISTER PACK
- 0045-0659 - Ultram
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 (0045-0659). 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 0045-0659-10 identifies a specific commercial package of 10 blister pack in 1 box / 10 tablet, coated in 1 blister pack of Ultram, labeled by Ortho-mcneil-janssen Pharmaceuticals, 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 Ortho-mcneil-janssen Pharmaceuticals, Inc. on March 03, 1995. The current certification is valid through March 31, 2012.
What are the primary indications for this medication?
See also Warning section. This medication is used to help relieve moderate to moderately severe pain. Tramadol is similar to opioid analgesics. It works in the brain to change how your body feels and responds to pain.
How is this Ortho-mcneil-janssen Pharmaceuticals, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00045065910. 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 Labeler segment to maintain the 5-4-2 structure.