Droxidopa Powder
NDC Package 65085-0071-3

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

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.

Droxidopa powders is droxidopa is used to treat symptoms of low blood pressure when standing, caused by a certain medical condition (neurogenic orthostatic hypotension-NOH). This formulation utilizes a powder delivery system. Marketed by Piramal Pharma Limited, this product is identified by NDC 65085-0071.

Identification & Billing

NDC Package Code
65085-0071-3
Package Description
15 kg in 1 DRUM
Product Code
65085-0071
11-Digit Billing Format
65085007103

Clinical Specifications

Proprietary Name
Droxidopa
Non-Proprietary Name
Droxidopa
Substance Name
Droxidopa
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)
DROXIDOPA 1 kg/kg
Usage Information
Droxidopa is used to treat symptoms of low blood pressure when standing, caused by a certain medical condition (neurogenic orthostatic hypotension-NOH). This medication can lessen symptoms of low blood pressure when standing (orthostatic hypotension), such as dizziness, lightheadedness, or the "feeling that you are about to black out." Droxidopa is used by people whose daily activities are severely affected by this condition, even after other treatments are used (such as support stockings, water bolus). It is thought to work by making the blood vessels become more narrow, which increases blood pressure.

Regulatory & Marketing

Labeler Name
Piramal Pharma Limited
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
01-02-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65085-0071). Click a package code to view its specific billing and regulatory data.

65085-0071-1
5 kg in 1 DRUM
65085-0071-2
10 kg in 1 DRUM
65085-0071-4
20 kg in 1 DRUM

* 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 65085-0071-3 identifies a specific commercial package of 15 kg in 1 drum of Droxidopa (UNFINISHED drug), drug for further processing labeled by Piramal Pharma Limited. This powder is formulated for use and contains droxidopa 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 02, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Droxidopa is used to treat symptoms of low blood pressure when standing, caused by a certain medical condition (neurogenic orthostatic hypotension-NOH). This medication can lessen symptoms of low blood pressure when standing (orthostatic hypotension), such as dizziness, lightheadedness, or the "feeling that you are about to black out." Droxidopa is used by people whose daily activities are severely affected by this condition, even after other treatments are used (such as support stockings, water bolus). It is thought to work by making the blood vessels become more narrow, which increases blood pressure.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65085007103. 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)
65085-0071-3
11-Digit CMS (5-4-2)
65085-0071-03

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