Tramadol Hydrochloride Powder
NDC Package 65085-0021-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Tramadol Hydrochloride powders is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a powder delivery system. Marketed by Piramal Pharma Limited, this product is identified by NDC 65085-0021.

Identification & Billing

NDC Package Code
65085-0021-1
Package Description
25 kg in 1 DRUM
Product Code
65085-0021
11-Digit Billing Format
65085002101

Clinical Specifications

Proprietary Name
Tramadol Hydrochloride
Non-Proprietary Name
Tramadol Hydrochloride
Substance Name
Tramadol Hydrochloride
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
TRAMADOL HYDROCHLORIDE 25 kg/25kg
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Piramal Pharma Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-22-2011
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 65085-0021-1 identifies a specific commercial package of 25 kg in 1 drum of Tramadol Hydrochloride (UNFINISHED drug), a bulk ingredient labeled by Piramal Pharma Limited. This powder is formulated for use and contains tramadol hydrochloride 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 Piramal Pharma Limited on January 22, 2011. The current certification is valid through December 31, 2026.

How is this Piramal Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65085002101. 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)
65085-0021-1
11-Digit CMS (5-4-2)
65085-0021-01

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