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  5. NDC Package Code: 60505-4318-3 Tolvaptan

NDC Package 60505-4318-3 Tolvaptan

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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:
60505-4318-3
Package Description:
30 TABLET in 1 BOTTLE
Product Code:
60505-4318
Proprietary Name:
Tolvaptan
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:
60505431803
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Apotex Corp.
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
TOLVAPTAN 30 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA207605
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-05-2022
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
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.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
60505-4318-01 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 60505-4318-3?

The NDC Packaged Code 60505-4318-3 is assigned to a package of 30 tablet in 1 bottle of Tolvaptan, a human prescription drug labeled by Apotex Corp.. The product's dosage form is tablet and is administered via oral form.

Is NDC 60505-4318 included in the NDC Directory?

Yes, Tolvaptan with product code 60505-4318 is active and included in the NDC Directory. The product was first marketed by Apotex Corp. on July 05, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 60505-4318-3?

The 11-digit format is 60505431803. 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
5-4-160505-4318-35-4-260505-4318-03