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  5. NDC Package Code: 43598-749-04 Sapropterin Dihydrochloride

NDC Package 43598-749-04 Sapropterin Dihydrochloride

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
43598-749-04
Package Description:
1 BOTTLE in 1 CARTON / 120 TABLET in 1 BOTTLE
Product Code:
43598-749
Proprietary Name:
Sapropterin Dihydrochloride
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:
43598074904
NDC to RxNorm Crosswalk:
  • RxCUI: 1486687 - sapropterin dihydrochloride 100 MG Oral Tablet
  • RxCUI: 1486687 - sapropterin dihydrochloride 100 MG Soluble Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Dr. Reddys Laboratories 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
  • 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:
    10-01-2020
    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
    43598-749-138000 BOTTLE in 1 CASE / 120 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43598-749-04?

    The NDC Packaged Code 43598-749-04 is assigned to a package of 1 bottle in 1 carton / 120 tablet in 1 bottle of Sapropterin Dihydrochloride, a human prescription drug labeled by Dr. Reddys Laboratories Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 43598-749 included in the NDC Directory?

    Yes, Sapropterin Dihydrochloride with product code 43598-749 is active and included in the NDC Directory. The product was first marketed by Dr. Reddys Laboratories Inc. on October 01, 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 43598-749-04?

    The 11-digit format is 43598074904. 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
    5-3-243598-749-045-4-243598-0749-04