Tolvaptan Tablet
NDC Package 46602-0029-5

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 tablets is a medication used by people who have a certain inherited kidney problem (autosomal dominant polycystic kidney disease-ADPKD). This formulation utilizes a tablet delivery system. Marketed by Otsuka Pharmaceutical Co., Ltd., this product is identified by NDC 46602-0029.

Identification & Billing

NDC Package Code
46602-0029-5
Package Description
100000 TABLET in 1 DRUM
Product Code
46602-0029
11-Digit Billing Format
46602002905

Clinical Specifications

Proprietary Name
Tolvaptan
Non-Proprietary Name
Tolvaptan
Substance Name
Tolvaptan
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Active Ingredient(s)
TOLVAPTAN 45 mg/1
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
Otsuka Pharmaceutical Co., Ltd.
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
09-01-2013
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 46602-0029-5 identifies a specific commercial package of 100000 tablet in 1 drum of Tolvaptan (UNFINISHED drug), drug for further processing labeled by Otsuka Pharmaceutical Co., Ltd.. This tablet 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 Otsuka Pharmaceutical Co., Ltd. on September 01, 2013. 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 Otsuka Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46602002905. 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)
46602-0029-5
11-Digit CMS (5-4-2)
46602-0029-05

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