Tolvaptan Tablet
NDC Package 67877-635-33

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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 Ascend Laboratories, Llc, this product is identified by NDC 67877-635 and is authorized under FDA application ANDA211891.

Identification & Billing

NDC Package Code
67877-635-33
Package Description
1 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Code
67877-635
11-Digit Billing Format
67877063533
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TOLVAPTAN 15 mg/1
Pharmacologic Class
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
Ascend Laboratories, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA211891
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-07-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (67877-635). Click a package code to view its specific billing and regulatory data.

67877-635-01
100 TABLET in 1 BOTTLE
67877-635-02
10 TABLET in 1 BOTTLE

* 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 67877-635-33 identifies a specific commercial package of 1 blister pack in 1 carton / 10 tablet in 1 blister pack of Tolvaptan, a human prescription drug labeled by Ascend Laboratories, Llc. This tablet is formulated for oral 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 Ascend Laboratories, Llc on September 07, 2022. 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 Ascend Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67877063533. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
67877-635-33
11-Digit CMS (5-4-2)
67877-0635-33

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