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  5. NDC Package Code: 59148-082-13 Jynarque

NDC Package 59148-082-13 Jynarque

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

Table of Contents

    1. Package Information
    2. 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:
59148-082-13
Package Description:
1 BOTTLE in 1 CARTON / 30 TABLET in 1 BOTTLE
Product Code:
59148-082
Proprietary Name:
Jynarque
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:
59148008213
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2044355 - JYNARQUE 15 MG Oral Tablet
  • RxCUI: 2044355 - tolvaptan 15 MG Oral Tablet [Jynarque]
  • RxCUI: 2044355 - Jynarque 15 MG Oral Tablet
  • RxCUI: 2044357 - JYNARQUE 30 MG Oral Tablet
  • RxCUI: 2044357 - tolvaptan 30 MG Oral Tablet [Jynarque]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Otsuka America Pharmaceutical, Inc.
    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 15 mg/1
    • Pharmacologic Class(es):
  • Vasopressin V2 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Vasopressin V2 Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA204441
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-23-2018
    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.

    Frequently Asked Questions

    What is NDC 59148-082-13?

    The NDC Packaged Code 59148-082-13 is assigned to a package of 1 bottle in 1 carton / 30 tablet in 1 bottle of Jynarque, a human prescription drug labeled by Otsuka America Pharmaceutical, Inc.. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 59148-082 included in the NDC Directory?

    Yes, Jynarque with product code 59148-082 is active and included in the NDC Directory. The product was first marketed by Otsuka America Pharmaceutical, Inc. on April 23, 2018 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 NDC billing unit for package 59148-082-13?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 59148-082-13?

    The 11-digit format is 59148008213. 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
    5-3-259148-082-135-4-259148-0082-13