Droxidopa Capsule
NDC Package 70710-1391-9

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Droxidopa capsules 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 capsule delivery system. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 70710-1391 and is authorized under FDA application ANDA211818.

Identification & Billing

NDC Package Code
70710-1391-9
Package Description
90 CAPSULE in 1 BOTTLE
Product Code
70710-1391
11-Digit Billing Format
70710139109
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Droxidopa
Non-Proprietary Name
Droxidopa
Substance Name
Droxidopa
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DROXIDOPA 300 mg/1
Pharmacologic Class
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
Zydus Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211818
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-19-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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 70710-1391-9 identifies a specific commercial package of 90 capsule in 1 bottle of Droxidopa, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. This capsule is formulated for oral 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 Zydus Pharmaceuticals Usa Inc. on February 19, 2021. 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 Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710139109. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 total billable units per package. 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)
70710-1391-9
11-Digit CMS (5-4-2)
70710-1391-09

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