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  5. NDC Package Code: 68135-300-02 Kuvan

NDC Package 68135-300-02 Kuvan

Sapropterin Dihydrochloride 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:
68135-300-02
Package Description:
120 TABLET in 1 BOTTLE
Product Code:
68135-300
Proprietary Name:
Kuvan
Non-Proprietary Name:
Sapropterin Dihydrochloride
Substance Name:
Sapropterin Dihydrochloride
Usage Information:
This medication is used along with diet changes for long-term treatment of a certain inherited disorder (phenylketonuria-PKU). It helps remove a certain chemical (phenylalanine) from the body. Too much phenylalanine in the body can cause brain damage.
11-Digit NDC Billing Format:
68135030002
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
120 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1111018 - sapropterin dihydrochloride 100 MG Powder for Oral Solution
  • RxCUI: 1111020 - KUVAN 100 MG Powder for Oral Solution
  • RxCUI: 1111020 - sapropterin dihydrochloride 100 MG Powder for Oral Solution [Kuvan]
  • RxCUI: 1111020 - Kuvan 100 MG Powder for Oral Solution
  • RxCUI: 1486687 - sapropterin dihydrochloride 100 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Biomarin 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):
  • SAPROPTERIN DIHYDROCHLORIDE 100 mg/1
    • Pharmacologic Class(es):
  • Breast Cancer Resistance Protein Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
  • Phenylalanine Hydroxylase Activator - [EPC] (Established Pharmacologic Class)
  • Phenylalanine Hydroxylase Activators - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA022181
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-14-2007
    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 68135-300-02?

    The NDC Packaged Code 68135-300-02 is assigned to a package of 120 tablet in 1 bottle of Kuvan, a human prescription drug labeled by Biomarin 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 120 billable units per package.

    Is NDC 68135-300 included in the NDC Directory?

    Yes, Kuvan with product code 68135-300 is active and included in the NDC Directory. The product was first marketed by Biomarin Pharmaceutical Inc. on December 14, 2007 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 68135-300-02?

    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 120.

    What is the 11-digit format for NDC 68135-300-02?

    The 11-digit format is 68135030002. 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
    5-3-268135-300-025-4-268135-0300-02