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  5. NDC Package Code: 60219-2009-9 Tiopronin

NDC Package 60219-2009-9 Tiopronin

Tablet, Delayed Release 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:
60219-2009-9
Package Description:
90 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code:
60219-2009
Proprietary Name:
Tiopronin
Non-Proprietary Name:
Tiopronin
Substance Name:
Tiopronin
Usage Information:
This medication is used to prevent kidney stones in people with a certain inherited disorder (cystinuria). Cystinuria occurs when there is too much of a certain natural substance (the amino acid cystine) in the urine, leading to formation of kidney stones. Tiopronin works by making cystine more dissolvable in the urine. This medication should be used in combination with other methods to prevent kidney stones (such as drinking plenty of water, taking alkali treatment, following a special diet).
11-Digit NDC Billing Format:
60219200909
NDC to RxNorm Crosswalk:
  • RxCUI: 2178079 - tiopronin 300 MG Delayed Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Ny Llc
    Dosage Form:
    Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • TIOPRONIN 300 mg/1
    • Pharmacologic Class(es):
  • Cystine Disulfide Reduction - [MoA] (Mechanism of Action)
  • N-substituted Glycines - [CS]
  • Reducing and Complexing Thiol - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA216278
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-16-2023
    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 60219-2009-9?

    The NDC Packaged Code 60219-2009-9 is assigned to a package of 90 tablet, delayed release in 1 bottle of Tiopronin, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. The product's dosage form is tablet, delayed release and is administered via oral form.

    Is NDC 60219-2009 included in the NDC Directory?

    Yes, Tiopronin with product code 60219-2009 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Ny Llc on August 16, 2023 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 60219-2009-9?

    The 11-digit format is 60219200909. 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 5-4-1 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
    5-4-160219-2009-95-4-260219-2009-09