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  5. NDC Package Code: 46602-0031-5 Tolvaptan

NDC Package 46602-0031-5 Tolvaptan

Tablet - View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
46602-0031-5
Package Description:
50000 TABLET in 1 DRUM
Product Code:
46602-0031
Non-Proprietary Name:
Tolvaptan
Substance Name:
Tolvaptan
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.
11-Digit NDC Billing Format:
46602003105
Product Type:
Drug For Further Processing
Labeler Name:
Otsuka Pharmaceutical Co., Ltd.
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Active Ingredient(s):
  • TOLVAPTAN 90 mg/1
    • Sample Package:
    N/A
    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 Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 46602-0031-5?

    The NDC Packaged Code 46602-0031-5 is assigned to an UNFINISHED drug package of 50000 tablet in 1 drum of Tolvaptan, drug for further processing labeled by Otsuka Pharmaceutical Co., Ltd.. The product's dosage form is tablet and is administered via form.

    Is NDC 46602-0031 included in the NDC Directory?

    Yes, Tolvaptan is an UNFINISHED PRODUCT with code 46602-0031 that is active and included in the NDC Directory. The product was first marketed by Otsuka Pharmaceutical Co., Ltd. on September 01, 2013 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 46602-0031-5?

    The 11-digit format is 46602003105. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-146602-0031-55-4-246602-0031-05