Tolvaptan Powder
NDC Package 72761-032-06

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.

Tolvaptan powders is a medication used by people who have a certain inherited kidney problem (autosomal dominant polycystic kidney disease-ADPKD). This formulation utilizes a powder delivery system. Marketed by Aurore Pharmaceuticals Private Limited, this product is identified by NDC 72761-032.

Identification & Billing

NDC Package Code
72761-032-06
Package Description
50 kg in 1 DRUM
Product Code
72761-032
11-Digit Billing Format
72761003206

Clinical Specifications

Proprietary Name
Tolvaptan
Non-Proprietary Name
Tolvaptan
Substance Name
Tolvaptan
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)
TOLVAPTAN 1 kg/kg
Usage Information
This medication is used by people who have a certain inherited kidney problem (autosomal dominant polycystic kidney disease-ADPKD). This inherited kidney problem leads to the growth of fluid-filled sacs (cysts) in your kidneys. Over time, the cysts grow in size, which can damage the way your kidneys work and lead to kidney failure. Tolvaptan belongs to a class of drugs known as vasopressin receptor antagonists. It works by slowing the growth of kidney cysts caused by ADPKD. This effect helps protect your kidneys from damage and failure. Different brands of this medication have different uses. Do not change brands of this medication unless directed by your doctor.

Regulatory & Marketing

Labeler Name
Aurore Pharmaceuticals Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
09-20-2024
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 72761-032-06 identifies a specific commercial package of 50 kg in 1 drum of Tolvaptan (UNFINISHED drug), a bulk ingredient labeled by Aurore Pharmaceuticals Private Limited. This powder is formulated for use and contains tolvaptan 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 Aurore Pharmaceuticals Private Limited on September 20, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used by people who have a certain inherited kidney problem (autosomal dominant polycystic kidney disease-ADPKD). This inherited kidney problem leads to the growth of fluid-filled sacs (cysts) in your kidneys. Over time, the cysts grow in size, which can damage the way your kidneys work and lead to kidney failure. Tolvaptan belongs to a class of drugs known as vasopressin receptor antagonists. It works by slowing the growth of kidney cysts caused by ADPKD. This effect helps protect your kidneys from damage and failure. Different brands of this medication have different uses. Do not change brands of this medication unless directed by your doctor.

How is this Aurore Pharmaceuticals Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72761003206. 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 (5-3-2)
72761-032-06
11-Digit CMS (5-4-2)
72761-0032-06

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