Jynarque Kit
NDC Package 59148-080-28

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

Package Information

Jynarque (tolvaptan) kits is a medication used by people who have a certain inherited kidney problem (autosomal dominant polycystic kidney disease-ADPKD). This formulation utilizes a kit delivery system. Marketed by Otsuka America Pharmaceutical, Inc., this product is identified by NDC 59148-080 and is authorized under FDA application NDA204441.

Identification & Billing

NDC Package Code
59148-080-28
Package Description
4 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK (59148-080-07)
Product Code
59148-080
11-Digit Billing Format
59148008028
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Jynarque
Non-Proprietary Name
Tolvaptan
Dosage Form
Kit - A packaged collection of related material.
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 America Pharmaceutical, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA204441
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-13-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59148-080-28 identifies a specific commercial package of 4 blister pack in 1 carton / 1 kit in 1 blister pack (59148-080-07) of Jynarque, a human prescription drug labeled by Otsuka America Pharmaceutical, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package. This kit is formulated for use and contains 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 America Pharmaceutical, Inc. on January 13, 2020. 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 America Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59148008028. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 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)
59148-080-28
11-Digit CMS (5-4-2)
59148-0080-28

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