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  5. NDC Package Code: 13668-691-03 Tiopronin

NDC Package 13668-691-03 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:
13668-691-03
Package Description:
300 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code:
13668-691
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:
13668069103
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
300 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2178075 - tiopronin 100 MG Delayed Release Oral Tablet
  • RxCUI: 2178079 - tiopronin 300 MG Delayed Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Torrent Pharmaceuticals Limited
    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 100 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:
    ANDA216990
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-30-2024
    Listing Expiration Date:
    12-31-2025
    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 13668-691-03?

    The NDC Packaged Code 13668-691-03 is assigned to a package of 300 tablet, delayed release in 1 bottle of Tiopronin, a human prescription drug labeled by Torrent Pharmaceuticals Limited. The product's dosage form is tablet, delayed release and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 300 billable units per package.

    Is NDC 13668-691 included in the NDC Directory?

    Yes, Tiopronin with product code 13668-691 is active and included in the NDC Directory. The product was first marketed by Torrent Pharmaceuticals Limited on January 30, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 13668-691-03?

    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 300.

    What is the 11-digit format for NDC 13668-691-03?

    The 11-digit format is 13668069103. 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
    5-3-213668-691-035-4-213668-0691-03