NDC Package 67877-637-01 Tolvaptan

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

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:
67877-637-01
Package Description:
100 TABLET in 1 BOTTLE
Product Code:
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:
67877063701
NDC to RxNorm Crosswalk:
  • RxCUI: 2044363 - tolvaptan 60 MG Oral Tablet
  • RxCUI: 849827 - tolvaptan 15 MG Oral Tablet
  • RxCUI: 849833 - tolvaptan 30 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Ascend Laboratories, Llc
    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):
    Sample Package:
    No
    FDA Application Number:
    ANDA211891
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-21-2020
    Listing Expiration Date:
    12-31-2024
    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
    67877-637-0210 TABLET in 1 BOTTLE
    67877-637-331 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 67877-637-01?

    The NDC Packaged Code 67877-637-01 is assigned to a package of 100 tablet in 1 bottle of Tolvaptan, a human prescription drug labeled by Ascend Laboratories, Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 67877-637 included in the NDC Directory?

    Yes, Tolvaptan with product code 67877-637 is active and included in the NDC Directory. The product was first marketed by Ascend Laboratories, Llc on May 21, 2020 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 67877-637-01?

    The 11-digit format is 67877063701. 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 5-3-2 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
    5-3-267877-637-015-4-267877-0637-01